The following data is part of a premarket notification filed by Hospital Concepts, Inc. with the FDA for Hci Y-connector.
| Device ID | K862484 |
| 510k Number | K862484 |
| Device Name: | HCI Y-CONNECTOR |
| Classification | Catheter, Urological |
| Applicant | HOSPITAL CONCEPTS, INC. 2701 W. ALAMEDA AVE., SUITE 406 Burbank, CA 91505 |
| Contact | Pradip Choksi |
| Correspondent | Pradip Choksi HOSPITAL CONCEPTS, INC. 2701 W. ALAMEDA AVE., SUITE 406 Burbank, CA 91505 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1986-09-09 |