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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 K062005
Device Name PORTEX EPIDURAL CATHETER
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact CYNTHIA ENGELHARDT
Correspondent
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact CYNTHIA ENGELHARDT
Regulation Number868.5120
Classification Product Code
BSO  
Date Received07/17/2006
Decision Date 10/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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