The following data is part of a premarket notification filed by Ni-med, Inc. with the FDA for I.v. Start Kits.
| Device ID | K875315 |
| 510k Number | K875315 |
| Device Name: | I.V. START KITS |
| Classification | I.v. Start Kit |
| Applicant | NI-MED, INC. 12624 W. 10 MILE RD. South Lyon, MI 48178 |
| Contact | Howard Meade |
| Correspondent | Howard Meade NI-MED, INC. 12624 W. 10 MILE RD. South Lyon, MI 48178 |
| Product Code | LRS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-02-17 |