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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
Applicant Contact TAMMY LOUNDS
Correspondent
Stryker Corp.
2725 Fairfield Rd.
P.O. Box 4085
Kalamazoo,  MI  49003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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