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510(k) K952396

REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION by Contour Fabricators of Florida, Inc. — Product Code BSY

K952396 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION". The FDA issued a decision of Substantially Equivalent on August 15, 1995. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
May 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Suction, Tracheobronchial
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
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)
  • K955678 — RNS STERILE DISPOSABLE PUNCTURE TRAY (February 21, 1996)
  • K955686 — RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY (February 21, 1996)
  • K955688 — RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY (February 21, 1996)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)

Other clearances for product code BSY

  • K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (November 25, 2003)
  • K992902 — AMBU HAND POWER SUCTION PUMP (October 25, 1999)
  • K982945 — DUAL PURPOSE CLOSED CATHETER (September 22, 1998)
  • K981910 — SUCTION CATHETER (August 24, 1998)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (March 11, 1997)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K960488 — NEO 2 LINE SUCTION SYSTEM (April 26, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)

FDA data resources