510(k) K910597

SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2 by Radix Group Intl. — Product Code HQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1991
Date Received
February 12, 1991
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