The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz/olympus Microscope System.
Device ID | K812234 |
510k Number | K812234 |
Device Name: | STORZ/OLYMPUS MICROSCOPE SYSTEM |
Classification | Microscope, Surgical |
Applicant | STORZ INSTRUMENT CO. 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 | 1981-08-11 |
Decision Date | 1981-09-11 |