The following data is part of a premarket notification filed by Project Marketing with the FDA for 56 Series Jet Nebulizer.
| Device ID | K021443 |
| 510k Number | K021443 |
| Device Name: | 56 SERIES JET NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PROJECT MARKETING 112 CAVISTON WAY Cary, NC 27560 |
| Contact | Terry O'brien |
| Correspondent | Terry O'brien PROJECT MARKETING 112 CAVISTON WAY Cary, NC 27560 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822383532919 | K021443 | 000 |
| 50822383975479 | K021443 | 000 |
| 00822383524504 | K021443 | 000 |