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510(k) K030393

OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER by Haag-Streit Holding AG — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2003
Date Received
February 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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