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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 K972412
Device Name PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact GREGORY R JONES
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact GREGORY R JONES
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/26/1997
Decision Date 09/10/1997
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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