The following data is part of a premarket notification filed by Visitec Co. with the FDA for Microsurgery Knife.
Device ID | K820618 |
510k Number | K820618 |
Device Name: | MICROSURGERY KNIFE |
Classification | Knife, Ophthalmic |
Applicant | VISITEC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-08 |
Decision Date | 1982-04-09 |