The following data is part of a premarket notification filed by Viggo Products with the FDA for Vasculon I.v. Cannulae.
| Device ID | K850278 |
| 510k Number | K850278 |
| Device Name: | VASCULON I.V. CANNULAE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VIGGO PRODUCTS OHMEDA P.O. BOX 7550 Madison, WI 53707 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle VIGGO PRODUCTS OHMEDA P.O. BOX 7550 Madison, WI 53707 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-04-09 |