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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 K934969
Device Name DUALGARD FACE SHIELD
Applicant
White Knight Healthcare
Bon Aire Rd.
Box 367
Childersburg,  AL  35044
Applicant Contact FRANK R DASTOLI
Correspondent
White Knight Healthcare
Bon Aire Rd.
Box 367
Childersburg,  AL  35044
Correspondent Contact FRANK R DASTOLI
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/14/1993
Decision Date 03/28/1994
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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