FDA 510(k) Application Details - K060780

Device Classification Name Tonometer, Ac-Powered

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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
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Regulation Number 886.1930

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Classification Product Code HKX
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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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