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FDA 510(k) Application Details - K150754
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K150754
Device Name
Device,Analysis,Anterior Segment
Applicant
SANTEC CORPORATION
5823 OHKUSA-NENJOZAKA
KOMAKI 485-0802 JP
Other 510(k) Applications for this Company
Contact
CHANGHO CHONG
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2015
Decision Date
10/02/2015
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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