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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 K882027
Device Name COMBO-SHIELD
Applicant
Bfd, Inc.
P.O. Drawer 909
Gardendale,  AL  35071
Applicant Contact PATRICK RUSSELL
Correspondent
Bfd, Inc.
P.O. Drawer 909
Gardendale,  AL  35071
Correspondent Contact PATRICK RUSSELL
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/13/1988
Decision Date 06/15/1988
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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