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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K955599
Device Name STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
Applicant
STRYKER CORP.
2725 FAIRFIELD RD.
P.O. BOX 4085
KALAMAZOO,  MI  49003 -4085
Applicant Contact TAMMY LOUNDS
Correspondent
STRYKER CORP.
2725 FAIRFIELD RD.
P.O. BOX 4085
KALAMAZOO,  MI  49003 -4085
Correspondent Contact TAMMY LOUNDS
Regulation Number878.4450
Classification Product Code
GDY  
Subsequent Product Code
LZN  
Date Received12/08/1995
Decision Date 02/22/1996
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
Recalls CDRH Recalls
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