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510(k) K082016

GDX VCC WITH ECC SOFTWARE by Carl Zeiss Meditec, Inc. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2009
Date Received
July 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Laser, Scanning
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

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