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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 K871906
Device Name UNIMED SURGEON'S GOWNS
Applicant
Unimed Hospital Supply Corp.
Post Office Box 549
Prairie View,  IL  60069
Applicant Contact R WIESBAUER
Correspondent
Unimed Hospital Supply Corp.
Post Office Box 549
Prairie View,  IL  60069
Correspondent Contact R WIESBAUER
Regulation Number878.4040
Classification Product Code
FYA  
Date Received05/15/1987
Decision Date 06/09/1987
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
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