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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 K030631
Device Name ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
Applicant
PROSURG, INC.
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
PROSURG, INC.
2195 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/28/2003
Decision Date 05/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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