FDA 510(k) Application Details - K955635

Device Classification Name Colposcope (And Colpomicroscope)

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510(K) Number K955635
Device Name Colposcope (And Colpomicroscope)
Applicant WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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Contact LAWRENCE E MAROCCO
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Regulation Number 884.1630

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Classification Product Code HEX
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Date Received 12/11/1995
Decision Date 05/07/1996
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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