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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 K897194
Device Name PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355 -8900
Applicant Contact DAVID A HARRELD
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355 -8900
Correspondent Contact DAVID A HARRELD
Regulation Number868.5120
Classification Product Code
BSO  
Date Received12/29/1989
Decision Date 06/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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