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510(k) K013820

FINN CHAMBER (R) by Epitest Ltd. OY — Product Code KXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2002
Date Received
November 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type

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