The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 M And 2.1 M, Megadyne Rf Sensor.
| Device ID | K200250 |
| 510k Number | K200250 |
| Device Name: | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 M And 2.1 M, Megadyne RF Sensor |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | Megadyne Medical Products, Inc. 11506 S State St Draper, UT 84020 |
| Contact | Sharon Sussex |
| Correspondent | Kweku Biney Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, OH 45242 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10614559104668 | K200250 | 000 |
| 10614559104651 | K200250 | 000 |
| 10614559104552 | K200250 | 000 |
| 10614559104545 | K200250 | 000 |
| 50614559104567 | K200250 | 000 |
| 10614559104569 | K200250 | 000 |