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510(k) K080698

GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP by Senorx, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2008
Date Received
March 12, 2008
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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