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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 K002699
Device Name PARIETEX COMPOSITE (PCO) MESH
Applicant
Medical Device Consultants, Inc.
49 Plain St.
N. Attleboro,  MA  02760 -4153
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Medical Device Consultants, Inc.
49 Plain St.
N. Attleboro,  MA  02760 -4153
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/30/2000
Decision Date 02/15/2001
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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