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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, Absorbable, Plastic And Reconstructive Surgery
510(k) Number K123128
Device Name SERI SURGICAL SCAFFOLD
Applicant
Allergan
200 Boston Ave.
Suite 3700
Medford,  MA  02155
Applicant Contact CONNIE GARRISON
Correspondent
Allergan
200 Boston Ave.
Suite 3700
Medford,  MA  02155
Correspondent Contact CONNIE GARRISON
Regulation Number878.3300
Classification Product Code
OXF  
Date Received10/04/2012
Decision Date 04/25/2013
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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