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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
Contact ashvin desai
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/28/2003
Decision Date 05/19/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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