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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K951927
Device Name COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
Applicant
CSEN LTD.
P.O. BOX 27476
JERUSALEM 91273
ISRAEL,  IL
Applicant Contact JOSEPH ELDOR
Correspondent
CSEN LTD.
P.O. BOX 27476
JERUSALEM 91273
ISRAEL,  IL
Correspondent Contact JOSEPH ELDOR
Regulation Number868.5120
Classification Product Code
BSO  
Date Received04/24/1995
Decision Date 05/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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