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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name vibrator for climax control of premature ejaculation
De Novo Number DEN130047
Device Name PROLONG
25 barker close
fishbourne, chichester
west sussex,  GB po18 8bj
Contact barry pearce
Regulation Number876.5025
Classification Product Code
Date Received11/18/2013
Decision Date 03/20/2015
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct