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510(k) K955683

RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY by Contour Fabricators of Florida, Inc. — Product Code MJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1996
Date Received
December 14, 1995
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

Other clearances by Contour Fabricators of Florida, Inc.

  • K955685 — RNS STERILE, DISPOSABLE CT BIOPSY TRAY (October 4, 1996)
  • K962040 — RNS ARTHROGRAM TRAY (June 25, 1996)
  • K955687 — RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (June 3, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K955684 — RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY (May 2, 1996)
  • K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (March 12, 1996)
  • K955686 — RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY (February 21, 1996)
  • K955678 — RNS STERILE DISPOSABLE PUNCTURE TRAY (February 21, 1996)
  • K955688 — RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY (February 21, 1996)
  • K952396 — REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION (August 15, 1995)

Other clearances for product code MJG

  • K080674 — PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (May 9, 2008)
  • K070836 — EXICLIP EXCS-M (April 20, 2007)
  • K983647 — ECHO-COAT ULTRASOUND NEEDLES (January 20, 1999)
  • K933324 — SKIN BIOPSY DEVICE (March 31, 1994)
  • K925870 — SPACER (May 19, 1993)
  • K922919 — DYNACYT BIOPSY ASPIRATION DEVICE (March 31, 1993)