The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Iv Prep Kit W/o Dressing (non-sterile).
| Device ID | K925018 |
| 510k Number | K925018 |
| Device Name: | IV PREP KIT W/O DRESSING (NON-STERILE) |
| Classification | I.v. Start 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 | LRS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-24 |
| Decision Date | 1993-08-27 |