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510(k) K933151

CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM by Contour Fabricators of Florida, Inc. — Product Code FRG

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
December 13, 1993
Date Received
June 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
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)
  • K955686 — RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY (February 21, 1996)
  • K955688 — RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY (February 21, 1996)
  • K955678 — RNS STERILE DISPOSABLE PUNCTURE TRAY (February 21, 1996)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)