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FDA 510(k) Application Details - K242058
Device Classification Name
More FDA Info for this Device
510(K) Number
K242058
Device Name
Digital Prism Correction Feature (DPCF)
Applicant
Apple Inc.
One Apple Park Way
Cupertino, CA 95014 US
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Contact
Ian Marcus
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
SCW
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More FDA Info for this Product Code
Date Received
07/15/2024
Decision Date
10/21/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K242058
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