The following data is part of a premarket notification filed by Rimeco Products, Inc. with the FDA for Rimeco Midstream Urine Collector.
| Device ID | K943752 |
| 510k Number | K943752 |
| Device Name: | RIMECO MIDSTREAM URINE COLLECTOR |
| Classification | Bag, Urine Collection, Newborn |
| Applicant | RIMECO PRODUCTS, INC. 7603-B9 FIRST PLACE DR. Oakwood Village, OH 44146 |
| Contact | Valentin Ribic |
| Correspondent | Valentin Ribic RIMECO PRODUCTS, INC. 7603-B9 FIRST PLACE DR. Oakwood Village, OH 44146 |
| Product Code | FOC |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1994-11-01 |