The following data is part of a premarket notification filed by Viggo Products with the FDA for Viggo Secalon T Catheter.
Device ID | K850460 |
510k Number | K850460 |
Device Name: | VIGGO SECALON T CATHETER |
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 | 1985-02-06 |
Decision Date | 1985-04-11 |