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510(k) K865103

KROM-X LENS SYSTEM by Neo Optics, Inc. — Product Code HQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
December 30, 1986
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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