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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 K854149
Device Name TSK STERIJECT STERILE EPIDURAL NEEDLE
Applicant
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Applicant Contact BRIAN D BOLLWAGE
Correspondent
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Correspondent Contact BRIAN D BOLLWAGE
Regulation Number868.5150
Classification Product Code
BSP  
Date Received10/11/1985
Decision Date 10/23/1985
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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