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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 K791438
Device Name BARRIER* C-ARM DRAPE
Applicant
SURGIKOS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SURGIKOS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/31/1979
Decision Date 08/28/1979
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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