The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Irrigation Channel Tubing, Model 100135.
| Device ID | K033695 |
| 510k Number | K033695 |
| Device Name: | IRRIGATION CHANNEL TUBING, MODEL 100135 |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | BYRNE MEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-11-25 |
| Decision Date | 2003-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20677964066188 | K033695 | 000 |
| 00677964058455 | K033695 | 000 |
| 00677964058448 | K033695 | 000 |
| 00677964058431 | K033695 | 000 |
| 00677964058424 | K033695 | 000 |
| 00677964058417 | K033695 | 000 |
| 00677964058400 | K033695 | 000 |
| 40677964031593 | K033695 | 000 |
| 00677964058493 | K033695 | 000 |
| 00677964058462 | K033695 | 000 |
| 00677964058479 | K033695 | 000 |
| 00677964058509 | K033695 | 000 |
| 00677964066061 | K033695 | 000 |
| 20677964066041 | K033695 | 000 |
| 20677964060414 | K033695 | 000 |
| 20677964060377 | K033695 | 000 |
| 20677964060360 | K033695 | 000 |
| 00677964060359 | K033695 | 000 |
| 00677964058950 | K033695 | 000 |
| 00677964058516 | K033695 | 000 |
| 00677964058486 | K033695 | 000 |