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FDA 510(k) Application Details - K220929
Device Classification Name
System, Image Management, Ophthalmic
More FDA Info for this Device
510(K) Number
K220929
Device Name
System, Image Management, Ophthalmic
Applicant
Merit CRO, Inc.
6527 Normandy Lane, Suite 100
Madison, WI 53719 US
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Contact
Yijuan Huang
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
NFJ
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More FDA Info for this Product Code
Date Received
03/31/2022
Decision Date
10/31/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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