The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for Vc Iii.
Device ID | K823011 |
510k Number | K823011 |
Device Name: | VC III |
Classification | Microscope, Surgical |
Applicant | TEKNAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EPT |
CFR Regulation Number | 878.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-13 |
Decision Date | 1982-11-08 |