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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 K791719
Device Name BARRIER & FACE MASK WITH INNER FACING
Applicant
Surgikos, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Surgikos, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/30/1979
Decision Date 10/04/1979
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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