The following data is part of a premarket notification filed by Conmed Electrosurgery with the FDA for System 7500-b Electrosurgical Unit; Abcflex Probe For Flexible Endoscopy.
Device ID | K050161 |
510k Number | K050161 |
Device Name: | SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED ELECTROSURGERY 14603 E. FREMONT AVE. Centennial, CO 80112 |
Contact | Pamela Vetter |
Correspondent | Pamela Vetter CONMED ELECTROSURGERY 14603 E. FREMONT AVE. Centennial, CO 80112 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-25 |
Decision Date | 2005-02-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20653405043437 | K050161 | 000 |
20653405043420 | K050161 | 000 |
10653405002987 | K050161 | 000 |