The following data is part of a premarket notification filed by Us Medical Innovations Llc with the FDA for Canady Vieira Hybrid Plasma Scalpel.
| Device ID | K113500 |
| 510k Number | K113500 |
| Device Name: | CANADY VIEIRA HYBRID PLASMA SCALPEL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | US MEDICAL INNOVATIONS LLC 2940 WINTER LAKE ROAD Lakeland, FL 33803 |
| Contact | Jerome Canady |
| Correspondent | Norbert Stuiber TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-11-25 |
| Decision Date | 2011-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B413PB4225550 | K113500 | 000 |
| B413AW4225540 | K113500 | 000 |
| B413AW4225520 | K113500 | 000 |