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510(k) K852105

MANAN UBK ULTRASONIC GUIDED BIOPSY KIT by Manan Manufacturing Co., Inc. — Product Code FCH

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
June 18, 1985
Date Received
May 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Biopsy, Without Biopsy Instruments
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

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Other clearances for product code FCH

  • K882673 — SIGMA 1 WOBBLER BIOPSY KIT (July 28, 1988)