The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Tuohy Point Epidural Needle (22g X 3 1/2).
| Device ID | K951411 |
| 510k Number | K951411 |
| Device Name: | MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2) |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | K. M Kroehnke |
| Correspondent | K. M Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-28 |
| Decision Date | 1995-05-01 |