The following data is part of a premarket notification filed by Mada Medical Products, Inc. with the FDA for Madavac 190.
| Device ID | K921611 |
| 510k Number | K921611 |
| Device Name: | MADAVAC 190 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072 |
| Contact | Jeffrey W Adam |
| Correspondent | Jeffrey W Adam MADA MEDICAL PRODUCTS, INC. 60 COMMERCE RD. Carlstadt, NJ 07072 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-03 |
| Decision Date | 1992-09-09 |