The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for A O Microscope Video System.
Device ID | K821865 |
510k Number | K821865 |
Device Name: | A O MICROSCOPE VIDEO SYSTEM |
Classification | Light, Microscope |
Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IBJ |
CFR Regulation Number | 864.3600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-24 |
Decision Date | 1982-07-14 |