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 |