The following data is part of a premarket notification filed by Pathfinder Intl. Corp. with the FDA for Closed Urinary Drainage Unit.
| Device ID | K843698 |
| 510k Number | K843698 |
| Device Name: | CLOSED URINARY DRAINAGE UNIT |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | PATHFINDER INTL. CORP. P.O. BOX 3104 Jacksonville , FL 32206 - |
| Contact | Robert E Seavey |
| Correspondent | Robert E Seavey PATHFINDER INTL. CORP. P.O. BOX 3104 Jacksonville , FL 32206 - |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-20 |
| Decision Date | 1984-12-17 |