The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Tuohy Epidural Needle 17g, Portex Tuohy Epidural Needle 18g.
| Device ID | K090261 |
| 510k Number | K090261 |
| Device Name: | PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Cindy Engelhardt |
| Correspondent | Cindy Engelhardt SMITHS MEDICAL ASD, 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 | 2009-02-03 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517050707 | K090261 | 000 |