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510(k) K110766

KOLPLUX SYSTEM by Kolplast CI Ltda — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2011
Date Received
March 18, 2011
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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