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FDA Medical Device #2954299 |
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Device Classification Name
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pad, heating, powered
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510(k) Number
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K072534
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Device Name
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BIO-MAT 2000
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Applicant
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RICHWAY INTL., INC.
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1314 south king st., suite 520
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honolulu, HI 96814
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Contact
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leroy klima
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Regulation Number
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890.5740
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Classification Product Code
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Date Received
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09/07/2007
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Decision Date
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02/08/2008
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Decision
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substantially equivalent (SE)
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Classification Advisory Committee
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Physical Medicine
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Review Advisory Committee
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Physical Medicine
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Statement/Summary/Purged Status
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Summary only
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summary
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summary
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Type
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Traditional
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Reviewed by Third Party
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No
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Expedited Review
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No
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Terms of Use