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510(k) K955685

RNS STERILE, DISPOSABLE CT BIOPSY TRAY by Contour Fabricators of Florida, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1996
Date Received
December 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Contour Fabricators of Florida, Inc.

  • 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)
  • K955688 — RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY (February 21, 1996)
  • K955686 — RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY (February 21, 1996)
  • K955678 — RNS STERILE DISPOSABLE PUNCTURE TRAY (February 21, 1996)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)
  • K952396 — REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION (August 15, 1995)

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