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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 K864311
Device Name STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)
Applicant
Clinitech, Inc.
1245 Norht Dearborn, #3s
Chicago,  IL  60610
Applicant Contact DENNIS CROWLEY
Correspondent
Clinitech, Inc.
1245 Norht Dearborn, #3s
Chicago,  IL  60610
Correspondent Contact DENNIS CROWLEY
Regulation Number878.4040
Classification Product Code
FYA  
Date Received11/03/1986
Decision Date 11/26/1986
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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