The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Urinary Leg Bag.
| Device ID | K896129 |
| 510k Number | K896129 |
| Device Name: | URINARY LEG BAG |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Varun Soni |
| Correspondent | Varun Soni CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-23 |
| Decision Date | 1990-04-16 |