The following data is part of a premarket notification filed by Thomas Medical, Inc. with the FDA for Thomas Medical Electrodes.
| Device ID | K022593 |
| 510k Number | K022593 |
| Device Name: | THOMAS MEDICAL ELECTRODES |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | THOMAS MEDICAL, INC. 4100-C NINE MCFARLAND DR. Alpharetta, GA 30004 |
| Contact | Thomas J Zinnanti |
| Correspondent | Thomas J Zinnanti THOMAS MEDICAL, INC. 4100-C NINE MCFARLAND DR. Alpharetta, GA 30004 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-05 |
| Decision Date | 2002-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852073002654 | K022593 | 000 |
| 10852073002361 | K022593 | 000 |
| 10852073002330 | K022593 | 000 |
| 10852073002323 | K022593 | 000 |
| 10852073002316 | K022593 | 000 |
| 10852073002309 | K022593 | 000 |
| 10852073002293 | K022593 | 000 |
| 10852073002286 | K022593 | 000 |
| 10852073002279 | K022593 | 000 |
| 10852073002255 | K022593 | 000 |
| 10852073002248 | K022593 | 000 |
| 10852073002378 | K022593 | 000 |
| 10852073002385 | K022593 | 000 |
| 10852073002644 | K022593 | 000 |
| 00852073002500 | K022593 | 000 |
| 10852073002491 | K022593 | 000 |
| 10852073002484 | K022593 | 000 |
| 10852073002477 | K022593 | 000 |
| 10852073002460 | K022593 | 000 |
| 10852073002453 | K022593 | 000 |
| 10852073002446 | K022593 | 000 |
| 10852073002439 | K022593 | 000 |
| 10852073002392 | K022593 | 000 |
| 10852073002231 | K022593 | 000 |