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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K043250
Device Name STRYKER PATIENT SPECIFIC POLYMER IMPLANT
Applicant
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact WADE T RUTKOSKIE
Correspondent
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact WADE T RUTKOSKIE
Regulation Number878.3500
Classification Product Code
KKY  
Date Received11/23/2004
Decision Date 04/15/2005
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
Recalls CDRH Recalls
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