The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Astra Tech Ab Lofric Primo Single Use Urinary Catheter.
| Device ID | K050874 |
| 510k Number | K050874 |
| Device Name: | ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER |
| Classification | Catheter, Urethral |
| Applicant | ASTRA TECH, INC. 20 MAIN STREET Northborough, MA 01532 |
| Contact | Bruce R Manning |
| Correspondent | Bruce R Manning ASTRA TECH, INC. 20 MAIN STREET Northborough, MA 01532 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-06 |
| Decision Date | 2005-05-05 |
| Summary: | summary |