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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 K992471
Device Name SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
Applicant
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5120
Classification Product Code
BSO  
Date Received07/26/1999
Decision Date 10/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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