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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, Antimicrobial
510(k) Number K761204
Device Name BARRIER IMPERVIOUS BACK TABLE COVER
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 Received12/07/1976
Decision Date 01/12/1977
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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