The following data is part of a premarket notification filed by Mali, Inc. with the FDA for Nir Lat Male External Catheter.
| Device ID | K855209 |
| 510k Number | K855209 |
| Device Name: | NIR LAT MALE EXTERNAL CATHETER |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | MALI, INC. 18455 BURBACK BLVD, STE 411 Tarzana, CA 91356 |
| Contact | Corole Hirsch |
| Correspondent | Corole Hirsch MALI, INC. 18455 BURBACK BLVD, STE 411 Tarzana, CA 91356 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-01-10 |