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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, Antimicrobial
510(k) Number K833121
Device Name BURLINGTON STERILE ANTIMICROBIAL STOCK
Applicant
Balfour, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Balfour, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/13/1983
Decision Date 01/25/1984
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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