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FDA 510(k) Application Details - K231051
Device Classification Name
Implant, Eye Valve
More FDA Info for this Device
510(K) Number
K231051
Device Name
Implant, Eye Valve
Applicant
New World Medical, Inc.
19763 Edison Court
Rancho Cucamonga, CA 91730 US
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Contact
Victor Arellano
Other 510(k) Applications for this Contact
Regulation Number
886.3920
More FDA Info for this Regulation Number
Classification Product Code
KYF
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More FDA Info for this Product Code
Date Received
04/13/2023
Decision Date
05/12/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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