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510(k) K050887

GONGDONG DISPOSABLE VAGINAL SPECULUM by Zhejiang Gongdong Medical Plastic Factory — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2005
Date Received
April 7, 2005
Clearance Type
Abbreviated
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

Other clearances by Zhejiang Gongdong Medical Plastic Factory

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