The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Conmed Irrigation Nozzle.
Device ID | K050992 |
510k Number | K050992 |
Device Name: | CONMED IRRIGATION NOZZLE |
Classification | Colonic Irrigation System |
Applicant | CONMED CORP. 525 FRENCH RD. Utica, NY 13502 |
Contact | Ira Duesler |
Correspondent | Ira Duesler CONMED CORP. 525 FRENCH RD. Utica, NY 13502 |
Product Code | KPL |
CFR Regulation Number | 876.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-19 |
Decision Date | 2005-07-14 |
Summary: | summary |