The following data is part of a premarket notification filed by Mabis Healthcare, Inc. with the FDA for Mabis Nb-02 Ultrasonic Nebulizer.
| Device ID | K990506 |
| 510k Number | K990506 |
| Device Name: | MABIS NB-02 ULTRASONIC NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MABIS HEALTHCARE, INC. 28690 BALLARD DR. Lake Forest, IL 60045 |
| Contact | Steven M Bisulca |
| Correspondent | Steven M Bisulca MABIS HEALTHCARE, INC. 28690 BALLARD DR. Lake Forest, IL 60045 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-17 |
| Decision Date | 1999-03-11 |