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FDA 510(k) Application Details - K170446
Device Classification Name
Colposcope (And Colpomicroscope)
More FDA Info for this Device
510(K) Number
K170446
Device Name
Colposcope (And Colpomicroscope)
Applicant
Lutech Industries, Inc.
105 Remington Blvd
Suite C
Ronkonkoma, NY 11779 US
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Contact
Leanna Vachula
Other 510(k) Applications for this Contact
Regulation Number
884.1630
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Classification Product Code
HEX
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More FDA Info for this Product Code
Date Received
02/14/2017
Decision Date
05/21/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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