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510(k) K080674

PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM by PAJUNK GmbH Medizintechnologie — Product Code MJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2008
Date Received
March 10, 2008
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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Other clearances for product code MJG

  • K070836 — EXICLIP EXCS-M (April 20, 2007)
  • K983647 — ECHO-COAT ULTRASOUND NEEDLES (January 20, 1999)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)
  • K933324 — SKIN BIOPSY DEVICE (March 31, 1994)
  • K925870 — SPACER (May 19, 1993)
  • K922919 — DYNACYT BIOPSY ASPIRATION DEVICE (March 31, 1993)