FDA 510(k) Application Details - K170446

Device Classification Name Colposcope (And Colpomicroscope)

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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
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Regulation Number 884.1630

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Classification Product Code HEX
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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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