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 |