510(k) K872506

MELANITE I by Aura Lens Products — Product Code HQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1987
Date Received
June 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Spectacle, Non-Custom (Prescription)
Device Class
Class I
Regulation Number
886.5844
Review Panel
OP
Submission Type