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FDA 510(k) Application Details - K152205
Device Classification Name
Tomography, Optical Coherence
More FDA Info for this Device
510(K) Number
K152205
Device Name
Tomography, Optical Coherence
Applicant
Heidelberg Engineering GmbH
Heidelberg 69121 DE
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Contact
Gerhard Zinser
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Regulation Number
886.1570
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Classification Product Code
OBO
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More FDA Info for this Product Code
Date Received
08/06/2015
Decision Date
05/06/2016
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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