The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Sims Portex Anesthesia Catheter.
Device ID | K994275 |
510k Number | K994275 |
Device Name: | SIMS PORTEX ANESTHESIA CATHETER |
Classification | Pump, Infusion |
Applicant | SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
Contact | Timothy J Talcott |
Correspondent | Timothy J Talcott SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-20 |
Decision Date | 2000-02-22 |
Summary: | summary |