510(k) K950519

SILHOUETTE SUNLIMITED ADIDAS by Silhouette Optical , Ltd. — Product Code HQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1995
Date Received
February 6, 1995
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