The following data is part of a premarket notification filed by Markoptic with the FDA for Markoptic Improved Arthroscope.
Device ID | K860607 |
510k Number | K860607 |
Device Name: | MARKOPTIC IMPROVED ARTHROSCOPE |
Classification | Arthroscope |
Applicant | MARKOPTIC 2329 N.BOSWORTH Chicago, IL 60614 |
Contact | Marko Vukovic |
Correspondent | Marko Vukovic MARKOPTIC 2329 N.BOSWORTH Chicago, IL 60614 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-19 |
Decision Date | 1986-03-05 |