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FDA 510(k) Application Details - K022054
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K022054
Device Name
Tonometer, Manual
Applicant
C.S.O. S.R.L.
197 BELVOIR RD.
WILLIAMSVILLE, NY 14221 US
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Contact
R. BRENT MINER
Other 510(k) Applications for this Contact
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
06/24/2002
Decision Date
08/06/2002
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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