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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K935255
Device Name ELDOR NEEDLE
Applicant
CSEN LTD.
P.O. BOX 27476
JERUSALEM 91273
ISRAEL,  IL
Applicant Contact J. ELDOR
Correspondent
CSEN LTD.
P.O. BOX 27476
JERUSALEM 91273
ISRAEL,  IL
Correspondent Contact J. ELDOR
Regulation Number868.5150
Classification Product Code
BSP  
Date Received11/01/1993
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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