FDA 510(k) Application Details - K081756

Device Classification Name Tonometer, Ac-Powered

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510(K) Number K081756
Device Name Tonometer, Ac-Powered
Applicant REICHERT INC.
3362 WALDEN AVE.
DEPEW, NY 14043 US
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Contact SANDRA BROWN
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Regulation Number 886.1930

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Classification Product Code HKX
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Date Received 06/20/2008
Decision Date 08/07/2008
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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