The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for I.v. Start Kit.
| Device ID | K924811 |
| 510k Number | K924811 |
| Device Name: | I.V. START KIT |
| Classification | I.v. Start Kit |
| Applicant | TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| Contact | Butler |
| Correspondent | Butler TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK Spartanburg, SC 29303 |
| 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 | 1992-09-25 |
| Decision Date | 1993-06-17 |