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510(k) K983647

ECHO-COAT ULTRASOUND NEEDLES by Sts Biopolymers — Product Code MJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1999
Date Received
October 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous, Biopsy
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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