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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
Predetermined Change
Control Plan Authorized		 No
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