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FDA 510(k) Application Details - K161776
Device Classification Name
Folders And Injectors, Intraocular Lens (Iol)
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510(K) Number
K161776
Device Name
Folders And Injectors, Intraocular Lens (Iol)
Applicant
LENSTEC INC.
1765 COMMERCE AVE.N.
ST. PETERSBURG, FL 33716 US
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Contact
JIMMY CHACKO
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
06/29/2016
Decision Date
11/29/2016
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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