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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 K121315
Device Name STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
Applicant
HOWMEDICA OSTEONICS CORP.
15 Dart Rd
NEWNAN,  GA  30265
Applicant Contact STEPHANIE FULLARD
Correspondent
HOWMEDICA OSTEONICS CORP.
15 Dart Rd
NEWNAN,  GA  30265
Correspondent Contact STEPHANIE FULLARD
Regulation Number878.3550
Classification Product Code
FWP  
Date Received05/02/2012
Decision Date 11/01/2012
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
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