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 |