FDA 510(k) Application Details - K963762

Device Classification Name Topographer, Corneal, Ac-Powered

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510(K) Number K963762
Device Name Topographer, Corneal, Ac-Powered
Applicant ECLIPSE VENTURES
108 SAYRE DR.
PRINCETON, NJ 08540 US
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Contact RICHARD G HUNTER
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Regulation Number 886.1350

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Classification Product Code MMQ
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Date Received 09/19/1996
Decision Date 12/23/1996
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

FDA Source Information for K963762


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