The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Aquapak Nebulizer Adaptors/reservoirs.
| Device ID | K141214 |
| 510k Number | K141214 |
| Device Name: | AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Contact | James A Cochie |
| Correspondent | James A Cochie Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-12 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704612745 | K141214 | 000 |
| 10197344007202 | K141214 | 000 |
| 10197344007226 | K141214 | 000 |
| 34026704627616 | K141214 | 000 |
| 34026704627647 | K141214 | 000 |
| 34026704627784 | K141214 | 000 |
| 34026704627814 | K141214 | 000 |
| 34026704627821 | K141214 | 000 |
| 34026704627913 | K141214 | 000 |
| 34026704627944 | K141214 | 000 |
| 24026704597042 | K141214 | 000 |
| 24026704597059 | K141214 | 000 |
| 24026704597134 | K141214 | 000 |
| 24026704597141 | K141214 | 000 |
| 24026704597158 | K141214 | 000 |
| 24026704597219 | K141214 | 000 |
| 24026704597226 | K141214 | 000 |
| 14026704611369 | K141214 | 000 |
| 20197344006028 | K141214 | 000 |