FDA 510(k) Application Details - K060573

Device Classification Name Tenaculum, Uterine

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510(K) Number K060573
Device Name Tenaculum, Uterine
Applicant VASCULAR CONTROL SYSTEMS, INC
32236-F PASEO ADELANTO
SAN JUAN CAPISTRANO, CA 92675 US
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Contact KATHLEEN ROBERTS
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Regulation Number 884.4530

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Classification Product Code HDC
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Date Received 03/06/2006
Decision Date 04/21/2006
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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