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510(k) K922845

BASIC DRESSING CHANGE TRAY SMP 102A by Specialty Medical Products Co. — Product Code FRG

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
December 29, 1992
Date Received
June 12, 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 Specialty Medical Products Co.

  • K924707 — VARIOUS ANESTHETIC KITS OR TRAYS (June 17, 1993)
  • K922533 — IV START KIT CUSTOM SMP # A-Z (March 23, 1993)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)

Other clearances for product code FRG

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  • 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)