FDA 510(k) Application Details - K032835

Device Classification Name Cannula, Manipulator/Injector, Uterine

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510(K) Number K032835
Device Name Cannula, Manipulator/Injector, Uterine
Applicant CATHETER RESEARCH, INC.
6131 WEST 80TH ST.
INDIANAPOLIS, IN 46278 US
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Contact JOHN A STEEN
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Regulation Number 000.0000

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Classification Product Code LKF
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Date Received 09/11/2003
Decision Date 12/11/2003
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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