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510(k) K042671

PLANMED SOPHIE NUANCE CLASSIC by Planmed OY — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2004
Date Received
September 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)