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510(k) K952406

REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION by Contour Fabricators of Florida, Inc. — Product Code KYZ

K952406 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION". The FDA issued a decision of Substantially Equivalent on August 7, 1995. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1995
Date Received
May 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
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)
  • K955688 — RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY (February 21, 1996)
  • K955686 — RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY (February 21, 1996)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)

Other clearances for product code KYZ

  • K201877 — OtoSet- Ear Cleaning System (November 5, 2020)
  • K102563 — SINGLE CANNULA EXTENDED APPLICATOR (March 15, 2011)
  • K092022 — TISSU TRANS HARVEST TUBING (August 17, 2009)
  • K050797 — TISSU-TRANS (July 13, 2005)
  • K991254 — QS DELIVERY SYSTEM (August 23, 1999)
  • K982435 — IRRIGATION SYRINGE KIT (November 6, 1998)
  • K974288 — ZEROWET SPLASHIELD (January 29, 1998)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K960725 — MARPP PRESSURE MONITORING SYSTEM (July 15, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)

FDA data resources