The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Sims Portex Epidural Catheter, 20g Model# 4910-16/17; 21g Model# 4910-18.
| Device ID | K992471 |
| 510k Number | K992471 |
| Device Name: | SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 |
| Classification | Catheter, Conduction, Anesthetic |
| 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 | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-26 |
| Decision Date | 1999-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942317707 | K992471 | 000 |