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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 K031955
Device Name MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
Applicant
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Applicant Contact KENNETH K KLEINHENZ
Correspondent
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/25/2003
Decision Date 09/22/2003
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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