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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 K001893
Device Name WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
Applicant
White Knight Healthcare, Inc.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ART WARD
Correspondent
White Knight Healthcare, Inc.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ART WARD
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/21/2000
Decision Date 04/02/2001
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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