The following data is part of a premarket notification filed by Kit Pak, Inc. with the FDA for Urinary Drainage Bag.
| Device ID | K934080 |
| 510k Number | K934080 |
| Device Name: | URINARY DRAINAGE BAG |
| Classification | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile |
| Applicant | KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Contact | Thomas J Sanders |
| Correspondent | Thomas J Sanders KIT PAK, INC. 825 CHASE AVE. Elk Grove Village, IL 60007 |
| Product Code | EYT |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1994-05-18 |