The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Maxi Aspirator.
Device ID | K902184 |
510k Number | K902184 |
Device Name: | MAXI ASPIRATOR |
Classification | Compressor, Air, Portable |
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 | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-14 |
Decision Date | 1991-02-12 |