The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Uncoated Electrosurgical Electrode.
| Device ID | K973346 |
| 510k Number | K973346 |
| Device Name: | UNCOATED ELECTROSURGICAL ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | John W Smith |
| Correspondent | John W Smith MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-05 |
| Decision Date | 1997-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559100701 | K973346 | 000 |
| 10614559101650 | K973346 | 000 |
| 10614559101643 | K973346 | 000 |
| 10614559101629 | K973346 | 000 |
| 10614559101612 | K973346 | 000 |
| 10614559101605 | K973346 | 000 |
| 10614559101582 | K973346 | 000 |
| 10614559101575 | K973346 | 000 |
| 10614559101568 | K973346 | 000 |
| 10614559101551 | K973346 | 000 |
| 10614559101544 | K973346 | 000 |
| 10614559101537 | K973346 | 000 |
| 10614559101520 | K973346 | 000 |
| 10614559101513 | K973346 | 000 |
| 30614559101517 | K973346 | 000 |
| 30614559101524 | K973346 | 000 |
| 30614559101531 | K973346 | 000 |
| 30614559103924 | K973346 | 000 |
| 30614559103566 | K973346 | 000 |
| 30614559101654 | K973346 | 000 |
| 30614559101647 | K973346 | 000 |
| 30614559101623 | K973346 | 000 |
| 30614559101616 | K973346 | 000 |
| 30614559101609 | K973346 | 000 |
| 30614559101593 | K973346 | 000 |
| 30614559101586 | K973346 | 000 |
| 30614559101579 | K973346 | 000 |
| 30614559101562 | K973346 | 000 |
| 30614559101555 | K973346 | 000 |
| 30614559101548 | K973346 | 000 |
| 10614559100707 | K973346 | 000 |