The following data is part of a premarket notification filed by Viggo Products with the FDA for Viggo Accessories For I.v. Therapy.
Device ID | K850769 |
510k Number | K850769 |
Device Name: | VIGGO ACCESSORIES FOR I.V. THERAPY |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-25 |
Decision Date | 1985-05-29 |