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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K855003
Device Name BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
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 Number876.1075
Classification Product Code
KNW  
Date Received12/13/1985
Decision Date 02/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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