The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for 3050 Sport-neb.
| Device ID | K964078 |
| 510k Number | K964078 |
| Device Name: | 3050 SPORT-NEB |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2879 "R" AVE. Adel, IA 50003 -8055 |
| Contact | Russell F Bird |
| Correspondent | Russell F Bird MEDICAL INDUSTRIES AMERICA, INC. 2879 "R" AVE. Adel, IA 50003 -8055 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-11 |
| Decision Date | 1997-01-10 |
| Summary: | summary |