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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 K894433
Device Name BATES BLANKET
Applicant
Joe B. Bates, MD, FAAP
612 S. Fleishel
Tyler,  TX  75701
Applicant Contact BATES, MD
Correspondent
Joe B. Bates, MD, FAAP
612 S. Fleishel
Tyler,  TX  75701
Correspondent Contact BATES, MD
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/17/1989
Decision Date 08/11/1989
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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