The following data is part of a premarket notification filed by Consolidated Products & Services, Inc. with the FDA for Urinary Drainage Unit.
| Device ID | K890551 |
| 510k Number | K890551 |
| Device Name: | URINARY DRAINAGE UNIT |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | CONSOLIDATED PRODUCTS & SERVICES, INC. 30 FAYETTE ST. North Quincy, MA 02171 |
| Contact | Richard Mcmanus |
| Correspondent | Richard Mcmanus CONSOLIDATED PRODUCTS & SERVICES, INC. 30 FAYETTE ST. North Quincy, MA 02171 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-02-28 |