510(k) K910179

OPTICAL FRAME by Australian Optical Co., Inc. — Product Code HQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1991
Date Received
January 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Frame, Spectacle
Device Class
Class I
Regulation Number
886.5842
Review Panel
OP
Submission Type