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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blade, saw, general & plastic surgery, surgical
510(k) Number K954483
Device Name STRYKER SAGITTAL SAW ATTACHMENT
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact TAMMY LOUNDS
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact TAMMY LOUNDS
Regulation Number878.4820
Classification Product Code
GFA  
Subsequent Product Code
GFF  
Date Received09/27/1995
Decision Date 01/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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