The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Urogard Urinary Drainage Bag.
| Device ID | K771210 |
| 510k Number | K771210 |
| Device Name: | UROGARD URINARY DRAINAGE BAG |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-05 |
| Decision Date | 1977-07-11 |