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510(k) K920480

DRESSING CHANG & WOUND MANAGEMENT by Cypress Medical Products, Ltd. — Product Code FRG

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
October 19, 1992
Date Received
January 29, 1992
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 Cypress Medical Products, Ltd.

  • K021676 — CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (July 12, 2002)
  • K012282 — STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE (August 6, 2001)
  • K972899 — CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (July 7, 1998)
  • K972849 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (May 28, 1998)
  • K972883 — ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) (February 26, 1998)
  • K952367 — CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE (July 5, 1995)
  • K950254 — CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE (March 31, 1995)
  • K950092 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY (February 27, 1995)
  • K950109 — CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER (February 27, 1995)
  • K945082 — CYPRESS MEDICAL PRODUCTS STETHOSCOPE (December 8, 1994)

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)