Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Rectal Insert
510(k) Number K122003
Device Name RENEW INSERT
Applicant
Renew Medical, Inc.
532 Emerson St.
Palo Alto,  CA  94301
Applicant Contact VICTORIA MACKINNON
Correspondent
Renew Medical, Inc.
532 Emerson St.
Palo Alto,  CA  94301
Correspondent Contact VICTORIA MACKINNON
Regulation Number876.5980
Classification Product Code
PBP  
Date Received07/09/2012
Decision Date 10/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT01475474
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-