The following data is part of a premarket notification filed by Byrne Medical Inc. with the FDA for Defendo (tm) Biopsy Valve For Olympus(r) And Fujinon(r) Endoscopes, Model 100301, Defendo(tm) Biopsy Valve For Pentax(r).
| Device ID | K090851 |
| 510k Number | K090851 |
| Device Name: | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) |
| Classification | Endoscope Channel Accessory |
| Applicant | BYRNE MEDICAL INC. 3150 POLLOK DR Conroe, TX 77303 |
| Contact | Jennifer James |
| Correspondent | Jennifer James BYRNE MEDICAL INC. 3150 POLLOK DR Conroe, TX 77303 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405063254 | K090851 | 000 |
| 20653405063237 | K090851 | 000 |
| 20653405063268 | K090851 | 000 |
| 10677964094702 | K090851 | 000 |
| 10677964090919 | K090851 | 000 |
| 10677964094689 | K090851 | 000 |
| 10677964094696 | K090851 | 000 |
| 00677964052453 | K090851 | 000 |
| 00677964055911 | K090851 | 000 |
| 00677964055928 | K090851 | 000 |
| 00677964060212 | K090851 | 000 |
| 00677964060250 | K090851 | 000 |
| 00677964060267 | K090851 | 000 |
| 00677964065057 | K090851 | 000 |
| 00677964065064 | K090851 | 000 |
| 00677964067174 | K090851 | 000 |
| 10653405063247 | K090851 | 000 |
| 00677964092992 | K090851 | 000 |