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510(k) K111692

TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC by Somatex Medical Technologies GmbH — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2011
Date Received
June 16, 2011
Clearance Type
Special
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

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  • 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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