The following data is part of a premarket notification filed by Vortran Medical Technology 1, Inc. with the FDA for Minineb.
| Device ID | K920443 |
| 510k Number | K920443 |
| Device Name: | MININEB |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J STREET, SUITE 354 Sacramento, CA 95819 |
| Contact | Gordon A Wong |
| Correspondent | Gordon A Wong VORTRAN MEDICAL TECHNOLOGY 1, INC. 3941 J STREET, SUITE 354 Sacramento, CA 95819 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-03 |
| Decision Date | 1992-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078000277 | K920443 | 000 |
| 10709078000178 | K920443 | 000 |
| 10709078000185 | K920443 | 000 |
| 10709078000192 | K920443 | 000 |
| 10709078000208 | K920443 | 000 |
| 10709078000215 | K920443 | 000 |
| 10709078000222 | K920443 | 000 |
| 00709078000232 | K920443 | 000 |
| 00709078000249 | K920443 | 000 |
| 00709078000256 | K920443 | 000 |
| 00709078000263 | K920443 | 000 |
| 10709078008198 | K920443 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MININEB 76261489 not registered Dead/Abandoned |
Sepracor Inc. 2001-05-23 |