The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Megadyne Foot Switch.
| Device ID | K191328 |
| 510k Number | K191328 |
| Device Name: | Megadyne Foot Switch |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | Megadyne Medical Products, Inc. 1506 S State St Draper, UT 84020 |
| Contact | Sharon Sussex |
| Correspondent | Ryoji Sakai 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 | 2019-05-16 |
| Decision Date | 2019-07-26 |
| Summary: | summary |