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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 K993148
Device Name STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact SUZANNE VELAZQUEZ
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact SUZANNE VELAZQUEZ
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/21/1999
Decision Date 10/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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