510(k) K931718

SPIRIT SHIELD by Eaton Medical Corp. — Product Code HQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1993
Date Received
April 6, 1993
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