FDA 510(k) Application Details - K973756

Device Classification Name Keratoscope, Ac-Powered

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510(K) Number K973756
Device Name Keratoscope, Ac-Powered
Applicant EYESYS TECHNOLOGIES, INC.
2776 BINGLE
HOUSTON, TX 77055 US
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Contact BETH A SOPER
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Regulation Number 886.1350

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Classification Product Code HLQ
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Date Received 10/02/1997
Decision Date 11/13/1997
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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