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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K850912
Device Name STERILE DISPOSABLE PN DRAPE SYSTEM
Applicant
BRANT-WALD SURGICALS, INC.
P.O. BOX 4962
OAK RIDGE,  TN  37831
Applicant Contact RAYBURN C WALDROP
Correspondent
BRANT-WALD SURGICALS, INC.
P.O. BOX 4962
OAK RIDGE,  TN  37831
Correspondent Contact RAYBURN C WALDROP
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/05/1985
Decision Date 05/03/1985
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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