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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, external aesthetic restoration, used with adhesive
510(k) Number K851668
Device Name PROSTHESIS OR SURGICAL PADS
Applicant
VIRGINIA HALL, INC.
4331-37 PIO NONO AVE.
MACON,  GA  31206
Applicant Contact JANET L DEGRANDIS
Correspondent
VIRGINIA HALL, INC.
4331-37 PIO NONO AVE.
MACON,  GA  31206
Correspondent Contact JANET L DEGRANDIS
Regulation Number878.3800
Classification Product Code
GBI  
Date Received04/23/1985
Decision Date 06/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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