The following data is part of a premarket notification filed by Venusa Ltd. with the FDA for Berlex Bolus/infusion(tm) Intravenous Admin Set.
| Device ID | K905518 |
| 510k Number | K905518 |
| Device Name: | BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET |
| Classification | System, X-ray, Angiographic |
| Applicant | VENUSA LTD. 95 NEWFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Contact | Linda A Bell |
| Correspondent | Linda A Bell VENUSA LTD. 95 NEWFIELD AVE. RARITAN CENTER Edison, NJ 08837 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-07 |
| Decision Date | 1991-06-21 |