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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 K914412
Device Name MASK, SURGICAL, DISPOSABLE
Applicant
Industries For the Blind
P.O. Box 3544
912 W. Lee St.
Greensboro,  NC  27402
Applicant Contact DEREK M DAVIS
Correspondent
Industries For the Blind
P.O. Box 3544
912 W. Lee St.
Greensboro,  NC  27402
Correspondent Contact DEREK M DAVIS
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/01/1991
Decision Date 12/19/1991
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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