The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Hyfrecator, #733.
| Device ID | K800617 |
| 510k Number | K800617 |
| Device Name: | HYFRECATOR, #733 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIRTCHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-18 |
| Decision Date | 1980-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40653405014394 | K800617 | 000 |
| 30845854648562 | K800617 | 000 |
| 30653405014380 | K800617 | 000 |
| 10653405014218 | K800617 | 000 |
| 40653405003183 | K800617 | 000 |
| 40653405003268 | K800617 | 000 |
| 40653405013526 | K800617 | 000 |
| 40653405013533 | K800617 | 000 |
| 40653405013540 | K800617 | 000 |
| 40653405013564 | K800617 | 000 |
| 40653405013571 | K800617 | 000 |
| 40653405014288 | K800617 | 000 |
| 40653405014387 | K800617 | 000 |
| 20653405014284 | K800617 | 000 |