The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Irrigator/aspirator Probe.
| Device ID | K915074 |
| 510k Number | K915074 |
| Device Name: | IRRIGATOR/ASPIRATOR PROBE |
| Classification | Cannula, Ophthalmic |
| Applicant | BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
| Contact | John Moberg |
| Correspondent | John Moberg BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-02-05 |