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FDA 510(k) Application Details - K970670
Device Classification Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
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510(K) Number
K970670
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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More FDA Info for this Product Code
Date Received
02/24/1997
Decision Date
05/06/1997
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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