The following data is part of a premarket notification filed by Brigam Medical, Inc. with the FDA for Pro-prep I.v. Start/scrub-prep/blood Culture Kit.
| Device ID | K926031 |
| 510k Number | K926031 |
| Device Name: | PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT |
| Classification | I.v. Start Kit |
| Applicant | BRIGAM MEDICAL, INC. 393 EAST FLEMING DR. POST OFFICE DRAWER 550 Morganton, NC 28655 |
| Contact | Kelly L Heath |
| Correspondent | Kelly L Heath BRIGAM MEDICAL, INC. 393 EAST FLEMING DR. POST OFFICE DRAWER 550 Morganton, NC 28655 |
| 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 | 1992-12-01 |
| Decision Date | 1993-06-07 |