FDA 510(k) Application Details - K023838

Device Classification Name Tonometer, Manual

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510(K) Number K023838
Device Name Tonometer, Manual
Applicant LUNEAU SA
BP 252
CHARTRES CEDEX 28005 FR
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Contact JEAN N YOUNG
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Regulation Number 886.1930

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Classification Product Code HKY
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Date Received 11/18/2002
Decision Date 02/20/2003
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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