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FDA 510(k) Application Details - K073053
Device Classification Name
Colposcope (And Colpomicroscope)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
884.1630
More FDA Info for this Regulation Number
Classification Product Code
HEX
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More FDA Info for this Product Code
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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