The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for E-z Clear Smoke Evacuation Electrosurgical Pencil;clear Nozzle Extention, Ulpa Filter, Charcoal Filter, Adapter.
| Device ID | K141587 |
| 510k Number | K141587 |
| Device Name: | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER |
| 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 | 2014-06-13 |
| Decision Date | 2015-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30614559104631 | K141587 | 000 |
| 30614559104198 | K141587 | 000 |
| 30614559104990 | K141587 | 000 |
| 10614559105320 | K141587 | 000 |
| 10614559105337 | K141587 | 000 |
| 10614559105344 | K141587 | 000 |
| 10614559105658 | K141587 | 000 |
| 10614559105757 | K141587 | 000 |
| 30614559105324 | K141587 | 000 |
| 30614559105348 | K141587 | 000 |
| 30614559105751 | K141587 | 000 |
| 30614559104570 | K141587 | 000 |
| 30614559105119 | K141587 | 000 |
| 30614559105652 | K141587 | 000 |
| 30614559104044 | K141587 | 000 |
| 30614559104327 | K141587 | 000 |
| 30614559104181 | K141587 | 000 |