The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Catheter Insertion Tray.
| Device ID | K922179 |
| 510k Number | K922179 |
| Device Name: | CATHETER INSERTION TRAY |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Contact | William A Hays |
| Correspondent | William A Hays MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-08 |
| Decision Date | 1993-07-02 |