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510(k) K900091

MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR by Onufryk Low Vision Ent. — Product Code HQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
January 5, 1990
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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