510(k) K935678

SUNGLASS FRAME by Australian Optical Co., Inc. — Product Code HQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1994
Date Received
November 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Device Class
Class I
Regulation Number
886.5850
Review Panel
OP
Submission Type