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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K760991
Device Name SURGINE FACE MASK
Applicant
Surgikos, Inc.
MD 
Correspondent
Surgikos, Inc.
MD 
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/05/1976
Decision Date 11/16/1976
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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