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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 K893634
Device Name MODIFIED STERILIZATION OF TUR APRONS
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 Number878.4040
Classification Product Code
FXX  
Date Received05/11/1989
Decision Date 06/23/1989
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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