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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 K070078
Device Name STRYKER T4 HYTREL TOGA
Applicant
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact PAULETTE D JOHNSON
Correspondent
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact PAULETTE D JOHNSON
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Code
FXY  
Date Received01/09/2007
Decision Date 02/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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