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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Chin, Internal
510(k) Number K091011
Device Name PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
Applicant
Surgical Technology Laboratories, Inc ("Stl")
610 Clemson Rd.
Columbia,  SC  29229
Applicant Contact MATHEW FAIRFAX
Correspondent
Surgical Technology Laboratories, Inc ("Stl")
610 Clemson Rd.
Columbia,  SC  29229
Correspondent Contact MATHEW FAIRFAX
Regulation Number878.3550
Classification Product Code
FWP  
Subsequent Product Code
LZK  
Date Received04/09/2009
Decision Date 04/22/2009
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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