The following data is part of a premarket notification filed by General Project S.r.l. with the FDA for Med Contour.
| Device ID | K091615 |
| 510k Number | K091615 |
| Device Name: | MED CONTOUR |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | GENERAL PROJECT S.R.L. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell GENERAL PROJECT S.R.L. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2010-05-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MED CONTOUR 77895893 4067856 Live/Registered |
GP Investimenti S.R.L. 2009-12-17 |