510(k) K920169

SUNGLASSES by Walgreen Co. — Product Code HQY

K920169 is an FDA 510(k) premarket notification submitted by Walgreen Co. for the device "SUNGLASSES". The FDA issued a decision of Substantially Equivalent on May 1, 1992. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1992
Date Received
January 13, 1992
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