The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for 605 Vacu-max.
| Device ID | K941961 |
| 510k Number | K941961 |
| Device Name: | 605 VACU-MAX |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2879 R AVE. Adel, IA 50003 -8055 |
| Contact | Mark D Hebenstreit |
| Correspondent | Mark D Hebenstreit MEDICAL INDUSTRIES AMERICA, INC. 2879 R AVE. Adel, IA 50003 -8055 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-22 |
| Decision Date | 1995-03-02 |