The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for A O Fiber Optic Illumination, 1185a.
Device ID | K821753 |
510k Number | K821753 |
Device Name: | A O FIBER OPTIC ILLUMINATION, 1185A |
Classification | Light Source, Photographic, Fiberoptic |
Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FCR |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-15 |
Decision Date | 1982-06-24 |