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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 EAST MILHAM AVE.
KALAMAZOO,  MI  49001 -6197
Applicant Contact TAMMY LOUDS
Correspondent
STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001 -6197
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
Recalls CDRH Recalls
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