The following data is part of a premarket notification filed by Mason-keller Corp. with the FDA for Kit,i.v. Start.
| Device ID | K940035 |
| 510k Number | K940035 |
| Device Name: | KIT,I.V. START |
| Classification | Vinyl Patient Examination Glove |
| Applicant | MASON-KELLER CORP. 119 HARRISON AVE. Roseland, NJ 07068 |
| Contact | Alfred C Caggia |
| Correspondent | Alfred C Caggia MASON-KELLER CORP. 119 HARRISON AVE. Roseland, NJ 07068 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-04 |
| Decision Date | 1994-06-03 |