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510(k) K092870

NON-STERILE DISPOSABLE VAGINAL SPECULUM by Kunshan Deyi Plastic Co., Ltd. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2010
Date Received
September 18, 2009
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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