FDA 510(k) Application Details - K001314

Device Classification Name Colposcope (And Colpomicroscope)

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510(K) Number K001314
Device Name Colposcope (And Colpomicroscope)
Applicant ALL-PRO IMAGING CORP.
70 CANTIAGUE ROCK RD.
P.O. BOX 870
HICKSVILLE, NY 11801 US
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Contact JOSEPH CAREY
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Regulation Number 884.1630

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Classification Product Code HEX
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Date Received 04/26/2000
Decision Date 07/25/2000
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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