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510(k) K844611

SINGLE BASIN SET by Packaging Technologies, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1984
Date Received
November 27, 1984
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 Packaging Technologies, Inc.

  • K881756 — STERILE SURGEONS GLOVES (June 1, 1988)
  • K863326 — BONE MARROW TRAY (September 16, 1986)
  • K861041 — ENHANCE (May 30, 1986)
  • K850544 — SHAVE PREP TRAY (March 12, 1985)
  • K850438 — RENAL BIOPSY TRAY (February 26, 1985)
  • K844613 — GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (January 10, 1985)
  • K844614 — IV START KIT (December 19, 1984)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K834074 — PERCUTANEOUS SHEATH INTRODUCER TRAY (March 19, 1984)
  • K834073 — CENTRAL VEIN CATHERIZATION TRAY CC-20 (February 28, 1984)

Other clearances for product code FRG

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  • 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)