FDA 510(k) Application Details - K132744

Device Classification Name Coagulator, Laparoscopic, Unipolar (And Accessories)

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510(K) Number K132744
Device Name Coagulator, Laparoscopic, Unipolar (And Accessories)
Applicant HALT MEDICAL INC.
131 Sand Creek Road, Suite B
Brentwood, CA 94513 US
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Contact CLARISA TATE
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Regulation Number 884.4160

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Classification Product Code HFG
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Date Received 09/03/2013
Decision Date 05/27/2014
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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