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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 K920305
Device Name PHARMASEAL CLEAR HUB SPINAL NEEDLE
Applicant
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Applicant Contact JAN ROBERTSON
Correspondent
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Correspondent Contact JAN ROBERTSON
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/22/1992
Decision Date 01/27/1993
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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