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510(k) K772024

RX LENS SERIES by Gentex Corporation — Product Code HQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1977
Date Received
October 26, 1977
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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