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510(k) K852403

AURALITE II by Aura Lens Products — Product Code HQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1985
Date Received
June 6, 1985
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

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