FDA 510(k) Application Details - K970673

Device Classification Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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510(K) Number K970673
Device Name Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant ALTEX VISION
2450 FULTON ST., SUITE 304
SAN FRANCISCO, CA 94118 US
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Contact LEONARD KASTRILEVICH
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Regulation Number 886.4150

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Classification Product Code HQE
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Date Received 02/24/1997
Decision Date 05/05/1997
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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