FDA 510(k) Application Details - K102847

Device Classification Name Curette, Suction, Endometrial (And Accessories)

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510(K) Number K102847
Device Name Curette, Suction, Endometrial (And Accessories)
Applicant JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
P.O. BOX 237-023
SHANGHAI 200237 CN
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Contact Diana Hong
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Regulation Number 884.1175

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Classification Product Code HHK
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Date Received 09/29/2010
Decision Date 04/14/2011
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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