Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-