FDA 510(k) Application Details - K073190

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

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510(K) Number K073190
Device Name Biomicroscope, Slit-Lamp, Ac-Powered
Applicant HUVITZ CO., LTD.
340 SHADY GROVE ROAD
FLINTVILLE, TN 37335 US
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Contact CHARLIE MACK
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Regulation Number 886.1850

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Classification Product Code HJO
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Date Received 11/13/2007
Decision Date 01/11/2008
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 Y
Expedited Review



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