FDA 510(k) Application Details - K073053

Device Classification Name Colposcope (And Colpomicroscope)

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510(K) Number K073053
Device Name Colposcope (And Colpomicroscope)
Applicant UNITED PRODUCTS & INSTRUMENTS, INC.
377 ROUTE 17 S
HASBROUCK, NJ 07604 US
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Contact GEORGE MYERS
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Regulation Number 884.1630

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Classification Product Code HEX
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Date Received 10/30/2007
Decision Date 11/15/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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