The following data is part of a premarket notification filed by Neotech Products, Inc. with the FDA for Urinary Drainage Bag Caddy.
| Device ID | K931727 |
| 510k Number | K931727 |
| Device Name: | URINARY DRAINAGE BAG CADDY |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
| Contact | Arnold Heyman |
| Correspondent | Arnold Heyman NEOTECH PRODUCTS, INC. 9135 ALABAMA AVENUE, SUITE F Chatsworth, CA 91311 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-03 |
| Decision Date | 1993-07-23 |