510(k) K960953

SUNGLASSES by Galilee Optics — Product Code HQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1996
Date Received
March 11, 1996
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