The following data is part of a premarket notification filed by Canady Technology, Llc with the FDA for Canady Plasma Probes.
Device ID | K052035 |
510k Number | K052035 |
Device Name: | CANADY PLASMA PROBES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CANADY TECHNOLOGY, LLC 24 RESEARCH DR. Hampton, VA 23666 |
Contact | Jerome Canady |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-07-28 |
Decision Date | 2005-08-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B413AW4225410 | K052035 | 000 |
B413AW4225400 | K052035 | 000 |
B413AW4225380 | K052035 | 000 |