The following data is part of a premarket notification filed by Us Medical Innovations, Llc with the FDA for Canady Plasma Smart Xl-1000 Electrosurgical Generator With Accessories.
Device ID | K192124 |
510k Number | K192124 |
Device Name: | Canady Plasma SMART XL-1000 Electrosurgical Generator With Accessories |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | US Medical Innovations, LLC 6930 Carroll Ave Takoma Park, MD 20912 |
Contact | David Hinds |
Correspondent | Tim Joiner Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-06 |
Decision Date | 2019-11-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B413XL10000 | K192124 | 000 |