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510(k) K062100

ARJOWRAP 47/100 AND 47/88 by Arjo Wiggins Medical, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2006
Date Received
July 24, 2006
Clearance Type
Special
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 Arjo Wiggins Medical, Inc.

  • K110954 — ARJORAD STERILE WRAP (August 24, 2012)
  • K931202 — STERILIZATION WRAP-STERISHEET (December 16, 1993)

Other clearances for product code FRG

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  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
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  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
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  • K242898 — Sterilization Pouches and Reels (February 21, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)