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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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More FDA Info for this Product Code
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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