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 |