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FDA 510(k) Application Details - K052912
Device Classification Name
Speculum, Vaginal, Nonmetal
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510(K) Number
K052912
Device Name
Speculum, Vaginal, Nonmetal
Applicant
ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD.
XUANMEN INDUSTRIAL ZONE, LUPU
TOWN, YUHUAN COUNTY
ZHEJIANG PROVINCE, P.R. 317608 CN
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PEIFANG XING
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Regulation Number
884.4530
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Classification Product Code
HIB
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Date Received
10/17/2005
Decision Date
12/15/2005
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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