The following data is part of a premarket notification filed by Ximed/prosure/injectx with the FDA for Electrosurgical Probes & Devices.
Device ID | K962593 |
510k Number | K962593 |
Device Name: | ELECTROSURGICAL PROBES & DEVICES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
Contact | Ashvin Desai |
Correspondent | Ashvin Desai XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-02 |
Decision Date | 1996-11-12 |