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510(k) K052912

YUSHENG DISPOSABLE VAGINAL SPECULUM by Zhejiang Yusheng Medical Instrument Co. , Ltd. — Product Code HIB

K052912 is an FDA 510(k) premarket notification submitted by Zhejiang Yusheng Medical Instrument Co. , Ltd. for the device "YUSHENG DISPOSABLE VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on December 15, 2005. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2005
Date Received
October 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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FDA data resources