The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Prostiva Rf Therapy Hand Piece Prostiva Rf Therapy Rf Generator.
| Device ID | K113380 |
| 510k Number | K113380 |
| Device Name: | PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDTRONIC INC. 7000 CENTRAL AVENUE NE Minneapolis, MN 55432 -3576 |
| Contact | Thomas Reichel |
| Correspondent | Thomas Reichel MEDTRONIC INC. 7000 CENTRAL AVENUE NE Minneapolis, MN 55432 -3576 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M87689290 | K113380 | 000 |