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510(k) K964289

EYE FIXATION SPECULUM by Eyefix, Inc. — Product Code HNC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1996
Date Received
October 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

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