The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Spinal Anesthesia Needles And Introducer Needles.
| Device ID | K983858 |
| 510k Number | K983858 |
| Device Name: | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES |
| Classification | Needle, Spinal, Short Term |
| 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 | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688061362 | K983858 | 000 |
| 15019517130584 | K983858 | 000 |
| 10351688051707 | K983858 | 000 |
| 10351688061287 | K983858 | 000 |
| 10351688061294 | K983858 | 000 |
| 10351688061300 | K983858 | 000 |
| 10351688061317 | K983858 | 000 |
| 10351688061324 | K983858 | 000 |
| 10351688061331 | K983858 | 000 |
| 10351688061355 | K983858 | 000 |
| 15019517039757 | K983858 | 000 |