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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rectal insert
510(K) Number K122003
Model 506FPP (TRAIL PACK), 507FPP (REGULAR), 508FPP (LARGE)
Device Name RENEW INSERT
Applicant
RENEW MEDICAL, INC.
532 emerson street
palo alto,  CA  94301
Contact victoria mackinnon
Regulation Number876.5980
Classification Product Code
PBP  
Date Received07/09/2012
Decision Date 10/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Clinical Trials NCT01475474
Reviewed by Third Party No
Expedited Review No
Combination Product No
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