The following data is part of a premarket notification filed by Teleflex Medical, Inc with the FDA for Rusch Flocath Hydrophilic Intermittent Catheter, Rusch Mmg Hydrophilic Intermittent Catheter.
| Device ID | K183461 |
| 510k Number | K183461 |
| Device Name: | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter |
| Classification | Catheter, Urethral |
| Applicant | Teleflex Medical, Inc 3015 Carrington Mill Blvd , Suite 600 North Morrisville, NC 27560 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl Teleflex Medical, Inc 3015 Carrington Mill Blvd , Suite 600 North Morrisville, NC 27560 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2019-05-08 |