510(k) K782118

FUL-VUE by American Optical Corp. — Product Code HKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1979
Date Received
December 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractor, Manual, Non-Powered, Including Phoropter
Device Class
Class I
Regulation Number
886.1770
Review Panel
OP
Submission Type