The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Medamicus Epidural Introducer.
| Device ID | K994097 |
| 510k Number | K994097 |
| Device Name: | MEDAMICUS EPIDURAL INTRODUCER |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Dennis Manson |
| Correspondent | Dennis Manson MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-03 |
| Decision Date | 2000-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994748027 | K994097 | 000 |