The following data is part of a premarket notification filed by The Kendal Co. with the FDA for The Kendall Urinary Output Monitor.
| Device ID | K852083 |
| 510k Number | K852083 |
| Device Name: | THE KENDALL URINARY OUTPUT MONITOR |
| Classification | Retractor, Self-retaining |
| Applicant | THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Contact | Mark W Wenzel |
| Correspondent | Mark W Wenzel THE KENDAL CO. ONE FEDERAL ST. Boston, MA 02110 -2003 |
| Product Code | FFO |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-09-20 |