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510(k) K943090

SUTURE REMOVAL TRAYS by Sterile Concepts, Inc. — Product Code FRG

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 22, 1994
Date Received
June 28, 1994
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 Sterile Concepts, Inc.

  • K951231 — ORTHOPEDIC PACKS (December 1, 1995)
  • K951081 — OB/GYN PACKS (November 13, 1995)
  • K952539 — RADIOLOGY PACKS (July 14, 1995)
  • K951478 — GENERAL AND PLASTIC SURGERY PACKS (June 13, 1995)
  • K944139 — DENTAL HYGIENE TRAY (December 15, 1994)
  • K943047 — IV START KITS (September 14, 1994)
  • K940864 — DENTIST WITH ASSISTANT PACK (August 2, 1994)
  • K943046 — SKIN STAPLE REMOVAL TRAYS (July 29, 1994)
  • K920763 — LACERATTION TRAY (September 28, 1992)

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)