The following data is part of a premarket notification filed by Ellman International, Inc. with the FDA for Ellman Noble Alloy Electrodes.
| Device ID | K071343 |
| 510k Number | K071343 |
| Device Name: | ELLMAN NOBLE ALLOY ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INTERNATIONAL, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary ELLMAN INTERNATIONAL, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-14 |
| Decision Date | 2008-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494106812 | K071343 | 000 |
| 00841494102029 | K071343 | 000 |
| 00841494101763 | K071343 | 000 |
| 00841494101602 | K071343 | 000 |
| 00841494101503 | K071343 | 000 |
| 00841494101497 | K071343 | 000 |
| 00841494101442 | K071343 | 000 |
| 00841494101398 | K071343 | 000 |
| 00841494101237 | K071343 | 000 |
| 00841494101145 | K071343 | 000 |
| 00841494100902 | K071343 | 000 |
| 00841494100896 | K071343 | 000 |
| 00841494102036 | K071343 | 000 |
| 00841494102043 | K071343 | 000 |
| 00841494103033 | K071343 | 000 |
| 00841494105358 | K071343 | 000 |
| 00841494104986 | K071343 | 000 |
| 00841494104825 | K071343 | 000 |
| 00841494104498 | K071343 | 000 |
| 00841494104450 | K071343 | 000 |
| 00841494104443 | K071343 | 000 |
| 00841494104436 | K071343 | 000 |
| 00841494103842 | K071343 | 000 |
| 00841494103408 | K071343 | 000 |
| 00841494103392 | K071343 | 000 |
| 00841494103385 | K071343 | 000 |
| 00841494100803 | K071343 | 000 |