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FDA 510(k) Application Details - K012416
Device Classification Name
Biomicroscope, Slit-Lamp, Ac-Powered
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510(K) Number
K012416
Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Applicant
NIDEK TECHNOLOGIES SRL
21911 ERIE LN.
LAKE FOREST, CA 92630 US
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Contact
CAROL PATTERSON
Other 510(k) Applications for this Contact
Regulation Number
886.1850
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Classification Product Code
HJO
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More FDA Info for this Product Code
Date Received
07/30/2001
Decision Date
10/26/2001
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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