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510(k) K182082

Tumark for Eviva, Tumark for Brevera by Somatex Medical Technologies GmbH — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2018
Date Received
August 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Somatex Medical Technologies GmbH

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  • K102771 — BIOPSY HANDY, MRI BIOPSY HANDY (June 24, 2011)
  • K093064 — TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 (February 17, 2010)
  • K073095 — TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 (March 19, 2008)

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