The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Universal Drainage Tray.
| Device ID | K961442 |
| 510k Number | K961442 |
| Device Name: | UNIVERSAL DRAINAGE TRAY |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Contact | Felix B Santos |
| Correspondent | Felix B Santos CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-05-09 |