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510(k) K142791

Spectra Soft Tissue Biopsy Needles by Spectra Medical Devices — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2015
Date Received
September 26, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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