Home / 510(k) Clearances / K820521

510(k) K820521

STERILIZATION WRAP by General Medical Co. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1982
Date Received
February 26, 1982
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 General Medical Co.

  • K926269 — PROCEDURE KIT (August 27, 1993)
  • K912975 — OPERAND LUBRICATING JELLY (September 27, 1991)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K903669 — GENESIS INSUFFLATING CATHETER (September 12, 1990)
  • K900110 — OPERAND* LUBRICATING JELLY (May 2, 1990)
  • K853635 — SUBDERM TM (December 20, 1985)
  • K844652 — C.A.S.E. CONTAINER (December 12, 1984)
  • K831320 — DRIONIC (July 19, 1983)
  • K820689 — C.S.R. WRAPPERS (April 9, 1982)
  • K802231 — AIR VIVA II (October 10, 1980)

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)