The following data is part of a premarket notification filed by Byrne Medical Inc. with the FDA for Defendo Disposable Air/water Valve Model 100304.
| Device ID | K102409 |
| 510k Number | K102409 |
| Device Name: | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 |
| 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 | 2010-08-24 |
| Decision Date | 2010-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00677964055935 | K102409 | 000 |