510(k) K791635
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