The following data is part of a premarket notification filed by Emmy Medical, Llc. with the FDA for Cystosure Plus Catheter.
| Device ID | K181346 |
| 510k Number | K181346 |
| Device Name: | CystoSure Plus Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Emmy Medical, LLC. 18 Hillside Drive Holliston, MA 01746 |
| Contact | Ronald Adams |
| Correspondent | Christine Santagate R&Q Solutions, LLC. 15 Standish Rd Norfolk, MA 02056 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2018-08-06 |
| Summary: | summary |