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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 K951928
Device Name DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
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 Number868.5150
Classification Product Code
BSP  
Date Received04/25/1995
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
Predetermined Change
Control Plan Authorized		 No
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