FDA 510(k) Application Details - K992998

Device Classification Name Tonometer, Manual

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510(K) Number K992998
Device Name Tonometer, Manual
Applicant AUTOMATED OPHTHALMICS, INC.
8253 GLEMAR RD.
ELLICOTT, MD 21043 US
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Contact NORMAN BICKMAN
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Regulation Number 886.1930

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Classification Product Code HKY
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Date Received 09/07/1999
Decision Date 01/10/2000
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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