FDA 510(k) Application Details - K161106

Device Classification Name Cannula, Suction, Uterine

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510(K) Number K161106
Device Name Cannula, Suction, Uterine
Applicant PANPAC MEDICAL CORPORATION
6F-1,2, NO. 202, SEC.3, TA-TONG ROAD
SHI-CHIH DIST. 22103 TW
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Contact YEN-MING PAN
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Regulation Number 884.5070

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Classification Product Code HGH
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Date Received 04/19/2016
Decision Date 01/13/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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