The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Irrigation/aspiration Tubing Set.
| Device ID | K911324 |
| 510k Number | K911324 |
| Device Name: | IRRIGATION/ASPIRATION TUBING SET |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
| Contact | Matthew E Bellin |
| Correspondent | Matthew E Bellin BIOMEDICAL DYNAMICS, INC. 12250 NICOLLET AVE. Burnsville, MN 55337 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-26 |
| Decision Date | 1991-06-24 |