The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Ao Teaching Attachment, Model Ta-1.
Device ID | K791635 |
510k Number | K791635 |
Device Name: | AO TEACHING ATTACHMENT, MODEL TA-1 |
Classification | Attachment, Teaching, For Endoscope |
Applicant | AMERICAN OPTICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FEA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-21 |
Decision Date | 1979-09-24 |