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FDA 510(k) Application Details - K121622
Device Classification Name
Tomography, Optical Coherence
More FDA Info for this Device
510(K) Number
K121622
Device Name
Tomography, Optical Coherence
Applicant
NIDEK CO., LTD.
1667 RIDGEWOOD RD
WADSWORTH, OH 44281 US
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Contact
LENA SATTLER
Other 510(k) Applications for this Contact
Regulation Number
886.1570
More FDA Info for this Regulation Number
Classification Product Code
OBO
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More FDA Info for this Product Code
Date Received
06/01/2012
Decision Date
03/14/2013
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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