FDA 510(k) Application Details - K032091

Device Classification Name Clamp, Circumcision

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510(K) Number K032091
Device Name Clamp, Circumcision
Applicant EMERGO GROUP, INC.
2454 MCMULLEN BOOTH ROAD
SUITE 427
CLERWATER, FL 33759 US
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Contact RENE' VAN DE ZANDE
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Regulation Number 884.4530

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Classification Product Code HFX
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Date Received 07/07/2003
Decision Date 03/08/2004
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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