The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Neb-u-mask System, Models 1895, 1896.
| Device ID | K080230 |
| 510k Number | K080230 |
| Device Name: | NEB-U-MASK SYSTEM, MODELS 1895, 1896 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Teleflex Medical, Inc. 24301 WOODSAGE DR Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden Teleflex Medical, Inc. 24301 WOODSAGE DR Bonita Springs, FL 34134 -2015 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-30 |
| Decision Date | 2008-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704643043 | K080230 | 000 |
| 34026704643036 | K080230 | 000 |
| 24026704661309 | K080230 | 000 |
| 24026704661293 | K080230 | 000 |
| 24026704558104 | K080230 | 000 |
| 24026704558098 | K080230 | 000 |