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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 K820543
Device Name BARRIER ANTIMICROBIAL INCISE DRAPE
Applicant
SURGIKOS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SURGIKOS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/02/1982
Decision Date 07/22/1982
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
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