FDA 510(k) Application Details - K141954

Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered

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510(K) Number K141954
Device Name Biomicroscope, Slit-Lamp, Ac-Powered
Applicant REICHERT, INC.
3362 WALDEN AVE.
DEPEW, NY 14043 US
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Contact THOMAS M HECKMANN
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Regulation Number 886.1850

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Classification Product Code HJO
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Date Received 07/18/2014
Decision Date 10/15/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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