The following data is part of a premarket notification filed by Astra Tech Ab with the FDA for Lofric Single Use Urinary Catheter.
| Device ID | K113424 |
| 510k Number | K113424 |
| Device Name: | LOFRIC SINGLE USE URINARY CATHETER |
| Classification | Catheter, Straight |
| Applicant | ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-04-17 |
| Summary: | summary |