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510(k) K060129

IGS VAGINAL SPECULUM by Innovative Gynecological Solutions, LLC — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2006
Date Received
January 18, 2006
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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