The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Abc Probe For Flexible Endoscopes.
Device ID | K990586 |
510k Number | K990586 |
Device Name: | CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Contact | Ira D Duesler |
Correspondent | Ira D Duesler CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-23 |
Decision Date | 1999-05-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20653405037887 | K990586 | 000 |
20653405032578 | K990586 | 000 |