The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for One Step Connect Leads (quattrode, Octrode, Cervitrode).
| Device ID | K960728 |
| 510k Number | K960728 |
| Device Name: | ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | NEUROMED, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 -4211 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes NEUROMED, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 -4211 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-22 |
| Decision Date | 1996-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067017222 | K960728 | 000 |
| 05414734406321 | K960728 | 000 |
| 05414734406024 | K960728 | 000 |
| 05414734401555 | K960728 | 000 |
| 05414734401531 | K960728 | 000 |