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510(k) K042742

HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) by Heidelberg Engineering — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2004
Date Received
October 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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