The following data is part of a premarket notification filed by General Project S.r.l. with the FDA for Mc1 Plus.
| Device ID | K161502 |
| 510k Number | K161502 |
| Device Name: | MC1 Plus |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | GENERAL PROJECT S.R.L. VIA DELLA GORA 15/19 Montespertoli, IT 50025 |
| Contact | Moreno Naldoni |
| Correspondent | Maureen O'connell O'CONNELL REGULATORY CONSULTANTS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-08-16 |
| Summary: | summary |