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FDA 510(k) Application Details - K070845
Device Classification Name
Colposcope (And Colpomicroscope)
More FDA Info for this Device
510(K) Number
K070845
Device Name
Colposcope (And Colpomicroscope)
Applicant
SOUNMED, INC.
6800 N.W. 77TH COURT
MIAMI, FL 33166 US
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Contact
RUBEN OLIVARES
Other 510(k) Applications for this Contact
Regulation Number
884.1630
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Classification Product Code
HEX
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More FDA Info for this Product Code
Date Received
03/27/2007
Decision Date
10/12/2007
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
N
Expedited Review
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