510(k) K974852

NON-PRESCRIPTION SUNGLASSES by Chia Hui Spectacles Mfg. Corp. — Product Code HQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
December 29, 1997
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