The following data is part of a premarket notification filed by Visitec Co. with the FDA for Vico Micro Surgical Instruments.
Device ID | K843592 |
510k Number | K843592 |
Device Name: | VICO MICRO SURGICAL INSTRUMENTS |
Classification | Passer |
Applicant | VISITEC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HWQ |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-12 |
Decision Date | 1984-10-05 |