The following data is part of a premarket notification filed by Mercury Enterprises, Inc. with the FDA for Intecare Pediatric Urine Collector.
| Device ID | K871789 |
| 510k Number | K871789 |
| Device Name: | INTECARE PEDIATRIC URINE COLLECTOR |
| Classification | Collector, Urine, Pediatric, For Indwelling Catheter |
| Applicant | MERCURY ENTERPRISES, INC. 1303 CLEAR SPRINGS TRACE, SUITE 207 Louisville, KY 40223 |
| Contact | William J Mason |
| Correspondent | William J Mason MERCURY ENTERPRISES, INC. 1303 CLEAR SPRINGS TRACE, SUITE 207 Louisville, KY 40223 |
| Product Code | FFH |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-06 |
| Decision Date | 1987-08-10 |