The following data is part of a premarket notification filed by Nellie Medical, Llc with the FDA for Kohli Urinary Drainage Catheter.
| Device ID | K172422 |
| 510k Number | K172422 |
| Device Name: | Kohli Urinary Drainage Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Nellie Medical, LLC 18 Hillside Drive Holliston, MA 01746 |
| Contact | Ronald Adams |
| Correspondent | Christine Santagate R&Q Solutions Boston, MA 02108 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2018-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866403000203 | K172422 | 000 |
| 00860239001328 | K172422 | 000 |