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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K860833
Device Name EPIDURAL ANESTHESIA TRAY
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact THOMAS D NICKEL
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact THOMAS D NICKEL
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received03/05/1986
Decision Date 04/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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