The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Mini-micron Circuit.
Device ID | K903499 |
510k Number | K903499 |
Device Name: | MINI-MICRON CIRCUIT |
Classification | Nebulizer (direct Patient Interface) |
Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel, IA 50003 |
Contact | Russell F Bird |
Correspondent | Russell F Bird MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel, IA 50003 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-03 |
Decision Date | 1991-03-27 |