The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Irrigation Tray W/ Bulb Syringe.
| Device ID | K924809 |
| 510k Number | K924809 |
| Device Name: | IRRIGATION TRAY W/ BULB SYRINGE |
| Classification | Syringe, Irrigating (non Dental) |
| 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 | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-24 |
| Decision Date | 1993-06-07 |