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FDA 510(k) Application Details - K060780
Device Classification Name
Tonometer, Ac-Powered
More FDA Info for this Device
510(K) Number
K060780
Device Name
Tonometer, Ac-Powered
Applicant
RYAZAN STATE INSTRUMENTS
151 EAST WALNUT STREET
LONG BEACH, NY 11561 US
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Contact
BORIS KUN
Other 510(k) Applications for this Contact
Regulation Number
886.1930
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Classification Product Code
HKX
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More FDA Info for this Product Code
Date Received
03/22/2006
Decision Date
04/06/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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