The following data is part of a premarket notification filed by Columbia Scientific Development Llc with the FDA for Columbia 600 Electrode, Columbia 06 Leadwire.
| Device ID | K080386 |
| 510k Number | K080386 |
| Device Name: | COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE |
| Classification | Electrode, Cutaneous |
| Applicant | COLUMBIA SCIENTIFIC DEVELOPMENT LLC 420 NW 11TH AVENUE SUITE 617 Portland, OR 97209 |
| Contact | Stephen Shulman |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850243006389 | K080386 | 000 |
| 00850243006143 | K080386 | 000 |
| 00850243006136 | K080386 | 000 |
| 00850243006129 | K080386 | 000 |
| 00850243006112 | K080386 | 000 |
| 00850243006105 | K080386 | 000 |
| 00850243006099 | K080386 | 000 |
| 00850243006082 | K080386 | 000 |
| 00850243006075 | K080386 | 000 |
| 00850243006068 | K080386 | 000 |
| 00850243006051 | K080386 | 000 |
| 00850243006044 | K080386 | 000 |
| 00850243006037 | K080386 | 000 |
| 00850243006020 | K080386 | 000 |
| 00850243006013 | K080386 | 000 |
| 00850243006150 | K080386 | 000 |
| 00850243006167 | K080386 | 000 |
| 00850243006372 | K080386 | 000 |
| 00850243006365 | K080386 | 000 |
| 00850243006358 | K080386 | 000 |
| 00850243006341 | K080386 | 000 |
| 00850243006334 | K080386 | 000 |
| 00850243006327 | K080386 | 000 |
| 00850243006303 | K080386 | 000 |
| 00850243006297 | K080386 | 000 |
| 00850243006280 | K080386 | 000 |
| 00850243006273 | K080386 | 000 |
| 00850243006266 | K080386 | 000 |
| 00850243006259 | K080386 | 000 |
| 00850243006242 | K080386 | 000 |
| 00850243006235 | K080386 | 000 |
| 00850243006006 | K080386 | 000 |