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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 K103445
Device Name ALACER SURGICAL SCAFFOLD
Applicant
Alacer Biomedical, Inc.
200 Boston Ave.
Suite 3700
Medford,  MA  02155
Applicant Contact CONNIE GARRISON
Correspondent
Alacer Biomedical, Inc.
200 Boston Ave.
Suite 3700
Medford,  MA  02155
Correspondent Contact CONNIE GARRISON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received11/24/2010
Decision Date 02/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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