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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 K931456
Device Name SURGICAL DRAPE AND GOWN TRAY
Applicant
Custom Medical Products, Ltd.
P.O. Box 8875
Asheville,  NC  28814
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
Custom Medical Products, Ltd.
P.O. Box 8875
Asheville,  NC  28814
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/23/1993
Decision Date 07/08/1994
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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