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FDA 510(k) Application Details - K191949
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
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510(K) Number
K191949
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
Johnson & Johnson Surgical Vision, Inc.
1700 East Saint Andrew Place
Santa Ana, CA 92705 US
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Contact
Silvia Jiang-Hughes
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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
07/22/2019
Decision Date
09/13/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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