FDA 510(k) Application Details - K970414

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

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510(K) Number K970414
Device Name Biomicroscope, Slit-Lamp, Ac-Powered
Applicant CON-S LTD.
ONE GALLERIA BOULEVARD,
SUITE 912
METAIRIE, LA 70002 US
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Contact HERBERT E KAUFMAN, M.D.
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Regulation Number 886.1850

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Classification Product Code HJO
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Date Received 01/23/1997
Decision Date 07/15/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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