510(k) K791635

AO TEACHING ATTACHMENT, MODEL TA-1 by American Optical Corp. — Product Code FEA

K791635 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "AO TEACHING ATTACHMENT, MODEL TA-1". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code FEA (Attachment, Teaching, For Endoscope), a Class I device regulated under 21 CFR 876.1500. American Optical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
August 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Teaching, For Endoscope
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type