The following data is part of a premarket notification filed by Byrne Medical Inc. with the FDA for Defendo Disposable Suction Valve Model 100305.
| Device ID | K102581 |
| 510k Number | K102581 |
| Device Name: | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 |
| Classification | Endoscope Channel Accessory |
| Applicant | BYRNE MEDICAL INC. 3150 POLLOK DR Conroe, TX 77303 |
| Contact | John Willis |
| Correspondent | John Willis 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 | 2010-09-08 |
| Decision Date | 2010-11-08 |
| Summary: | summary |