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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K944393
Device Name STRYKER STERI-SHIELD SURGICAL APPAREL
Applicant
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact TAMMY LOUDS
Correspondent
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact TAMMY LOUDS
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/09/1994
Decision Date 08/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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