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FDA 510(k) Application Details - K023676
Device Classification Name
Tonometer, Ac-Powered
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
886.1930
More FDA Info for this Regulation Number
Classification Product Code
HKX
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More FDA Info for this Product Code
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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