The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Abc D-flex Probe.
Device ID | K151229 |
510k Number | K151229 |
Device Name: | ABC D-FLEX PROBE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORPORATION 525 FRENCH ROAD Utica, NY 11502 |
Contact | Sandy Leclair |
Correspondent | Lisa B Anderson CONMED CORPORATION 525 FRENCH ROAD Utica, NY 11502 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-07 |
Decision Date | 2016-06-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20653405082504 | K151229 | 000 |
20653405082498 | K151229 | 000 |