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510(k) K093521

GDXPRO by Carl Zeiss Meditec, Inc. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2009
Date Received
November 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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Other clearances for product code MYC

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  • K180293 — Retia 2 (May 30, 2018)
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