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FDA 510(k) Application Details - K031639
Device Classification Name
Colposcope (And Colpomicroscope)
More FDA Info for this Device
510(K) Number
K031639
Device Name
Colposcope (And Colpomicroscope)
Applicant
INTERMED GROUP, INC.
3550 23RD AVE. SOUTH, SUITE #1
LAKE WORTH, FL 33461 US
Other 510(k) Applications for this Company
Contact
GEORGE GARAMY, JR.
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
05/27/2003
Decision Date
08/22/2003
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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