The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Suction Coagulator.
| Device ID | K072559 |
| 510k Number | K072559 |
| Device Name: | SUCTION COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020 |
| Contact | Ronda Magneson |
| Correspondent | Ronda Magneson 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 | 2007-09-11 |
| Decision Date | 2007-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559102934 | K072559 | 000 |
| 10614559105139 | K072559 | 000 |
| 10614559105146 | K072559 | 000 |
| 10614559105153 | K072559 | 000 |
| 10614559105160 | K072559 | 000 |
| 30614559103443 | K072559 | 000 |
| 30614559103450 | K072559 | 000 |
| 30614559105126 | K072559 | 000 |
| 30614559105133 | K072559 | 000 |
| 30614559105140 | K072559 | 000 |
| 30614559105157 | K072559 | 000 |
| 30614559105164 | K072559 | 000 |
| 30614559102798 | K072559 | 000 |
| 30614559102903 | K072559 | 000 |
| 30614559102910 | K072559 | 000 |
| 30614559102927 | K072559 | 000 |
| 10614559105122 | K072559 | 000 |