The following data is part of a premarket notification filed by Ep Medical, Inc. with the FDA for Absorbent, Disposable Urinary Drainage Bag.
| Device ID | K901320 |
| 510k Number | K901320 |
| Device Name: | ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | EP MEDICAL, INC. 139 YORK AVE. Kensington, CA 94707 |
| Contact | Dianne Eastman |
| Correspondent | Dianne Eastman EP MEDICAL, INC. 139 YORK AVE. Kensington, CA 94707 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-21 |
| Decision Date | 1991-01-25 |