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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K813360
Device Name DERMAFILE (CAT. # 38
Applicant
EXCO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EXCO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/30/1981
Decision Date 03/18/1982
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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