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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K963502
Device Name CSCO FOREHEAD FIXATION SYSTEM
Applicant
Howmedica Corp.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Applicant Contact KRISTYN R WASKI
Correspondent
Howmedica Corp.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Correspondent Contact KRISTYN R WASKI
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/03/1996
Decision Date 10/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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