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510(k) K071886

SELF SEAL STERILIZATION POUCH by Shanghai Jianzhong Medical Packaging Co., Ltd. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2007
Date Received
July 9, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • 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)