The following data is part of a premarket notification filed by Neotech Products, Inc. with the FDA for Uro-tote Leg Bag.
| Device ID | K921024 |
| 510k Number | K921024 |
| Device Name: | URO-TOTE LEG BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
| Contact | Thomas R Thornbury |
| Correspondent | Thomas R Thornbury NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-09-02 |