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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K974540
Device Name SIS HERNIA REPAIR DEVICE
Applicant
SENTRON MEDICAL, INC.
4445 LAKE FOREST DR.
SUITE 600
CINCINNATI,  OH  45242
Applicant Contact ROBERT J MORFF
Correspondent
SENTRON MEDICAL, INC.
4445 LAKE FOREST DR.
SUITE 600
CINCINNATI,  OH  45242
Correspondent Contact ROBERT J MORFF
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/03/1997
Decision Date 05/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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