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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 K071470
Device Name IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
Applicant
Implantech Associates, Inc.
6025 Nicolle St., Suite B
Ventura,  CA  93003
Applicant Contact STEPHEN MEADE
Correspondent
Implantech Associates, Inc.
6025 Nicolle St., Suite B
Ventura,  CA  93003
Correspondent Contact STEPHEN MEADE
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/29/2007
Decision Date 08/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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