The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Hudson Rci Aquapak Sterile Prefilled Nebulizers.
| Device ID | K153010 |
| 510k Number | K153010 |
| Device Name: | Hudson RCI AquaPak Sterile Prefilled Nebulizers |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Brian Gall |
| Correspondent | Brian Gall Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-14 |
| Decision Date | 2016-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704391893 | K153010 | 000 |
| 24026704391411 | K153010 | 000 |
| 24026704391404 | K153010 | 000 |