FDA 510(k) Application Details - K023676

Device Classification Name Tonometer, Ac-Powered

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510(K) Number K023676
Device Name Tonometer, Ac-Powered
Applicant OPTILASA S.L.
338 ARTURO SORIA ST.
MADRID 28033 ES
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Contact JOSE M BOBES
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Regulation Number 886.1930

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Classification Product Code HKX
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Date Received 11/01/2002
Decision Date 04/24/2003
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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