The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Beamer Argon Snare Probe.
Device ID | K081580 |
510k Number | K081580 |
Device Name: | BEAMER ARGON SNARE PROBE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORPORATION 129 CONCORD RD. BLDG. #3 Billerica, MA 01821 |
Contact | Karen Provencher |
Correspondent | Kachi Enyinna INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2008-06-05 |
Decision Date | 2008-06-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10653405064206 | K081580 | 000 |
10653405064190 | K081580 | 000 |
10653405064183 | K081580 | 000 |
10653405064176 | K081580 | 000 |
10653405064169 | K081580 | 000 |