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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K943809
Device Name MONOGARD FACE SHIELD
Applicant
White Knight Healthcare
175 Deaveaview Rd.
P.O.Box 6874
Ashville,  NC  28806
Applicant Contact FRANK R DASTOLI
Correspondent
White Knight Healthcare
175 Deaveaview Rd.
P.O.Box 6874
Ashville,  NC  28806
Correspondent Contact FRANK R DASTOLI
Regulation Number878.4040
Classification Product Code
LYU  
Date Received08/04/1994
Decision Date 11/28/1994
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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