The following data is part of a premarket notification filed by Epimed International with the FDA for Rk Epidural Needle.
| Device ID | K072005 |
| 510k Number | K072005 |
| Device Name: | RK EPIDURAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | EPIMED INTERNATIONAL 141 SAL LANDRIO DR. Johnstown, NY 12095 |
| Contact | Katie Alexander |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2008-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788020038 | K072005 | 000 |
| 10818788020021 | K072005 | 000 |
| 10818788020014 | K072005 | 000 |
| 10818788020007 | K072005 | 000 |