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FDA 510(k) Application Details - K161194
Device Classification Name
Tomography, Optical Coherence
More FDA Info for this Device
510(K) Number
K161194
Device Name
Tomography, Optical Coherence
Applicant
CARL ZEISS MEDITEC, INC.
5160 HACIENDA DRIVE
DUBLIN, CA 94568 US
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Contact
CHRISTINE DUNBAR
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
04/27/2016
Decision Date
10/26/2016
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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