The following data is part of a premarket notification filed by Astra Meditec Ab with the FDA for Lofric(r), Lofric(r) Cath-kit.
| Device ID | K896750 |
| 510k Number | K896750 |
| Device Name: | LOFRIC(R), LOFRIC(R) CATH-KIT |
| Classification | Catheter, Urological |
| Applicant | ASTRA MEDITEC AB P.O. BOX 14 S-4321 21 MOLNDAL Sweden, SE |
| Contact | Agneta Svensson |
| Correspondent | Agneta Svensson ASTRA MEDITEC AB P.O. BOX 14 S-4321 21 MOLNDAL Sweden, SE |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1990-08-06 |