The following data is part of a premarket notification filed by The Kendal Co. with the FDA for Kendall Curity Urinary Output Monitor Drainage Bag.
| Device ID | K852085 |
| 510k Number | K852085 |
| Device Name: | KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| 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 | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-08-07 |