The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Misonix Irrigation System Moedl Bc20p.
| Device ID | K013417 |
| 510k Number | K013417 |
| Device Name: | MISONIX IRRIGATION SYSTEM MOEDL BC20P |
| Classification | Catheter, Irrigation |
| Applicant | MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Contact | Albert F Clancy |
| Correspondent | Albert F Clancy MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2002-01-10 |
| Summary: | summary |