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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K951984
Device Name WHITE KNIGHT SURGEON'S VEST
Applicant
White Knight Healthcare
P.O. Box 6874
Asheville,  NC  28816
Applicant Contact FRANK R DASTOLI
Correspondent
White Knight Healthcare
P.O. Box 6874
Asheville,  NC  28816
Correspondent Contact FRANK R DASTOLI
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/27/1995
Decision Date 07/25/1995
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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