The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Csecure Combined Spinal/epidural Anesthesia System With Lock.
| Device ID | K993619 |
| 510k Number | K993619 |
| Device Name: | CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| 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 | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-26 |
| Decision Date | 2000-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688002310 | K993619 | 000 |
| 10351688047861 | K993619 | 000 |
| 10351688047854 | K993619 | 000 |