FDA 510(k) Application Details - K830917

Device Classification Name Prosthesis, Penile

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510(K) Number K830917
Device Name Prosthesis, Penile
Applicant MEDICAL ENGINEERING CORP.

, US
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Regulation Number 876.3630

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Classification Product Code FAE
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Date Received 03/22/1983
Decision Date 04/12/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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