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FDA 510(k) Application Details - K182965
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
More FDA Info for this Device
510(K) Number
K182965
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
AST Products, Inc.
9 Linnell Circle
Billerica, MA 01821 US
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Contact
William Lee
Other 510(k) Applications for this Contact
Regulation Number
886.4300
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Classification Product Code
MSS
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More FDA Info for this Product Code
Date Received
10/25/2018
Decision Date
03/29/2019
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
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