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FDA 510(k) Application Details - K232088
Device Classification Name
System, Image Management, Ophthalmic
More FDA Info for this Device
510(K) Number
K232088
Device Name
System, Image Management, Ophthalmic
Applicant
Altris, Inc.
125 South Clark Street, 17th Floor
Chicago, IL 60603 US
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Contact
Andrew Kuropyatnyk
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
07/13/2023
Decision Date
07/31/2023
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
Y
Expedited Review
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