FDA 510(k) Application Details - K992835

Device Classification Name Tonometer, Manual

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510(K) Number K992835
Device Name Tonometer, Manual
Applicant CSO
197 BELVOIR RD.
WILLIAMSVILLE, NY 14221 US
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Contact R. BRENT MINER
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Regulation Number 886.1930

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Classification Product Code HKY
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Date Received 08/23/1999
Decision Date 06/06/2000
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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