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510(k) K241565

Sterilization Package/Reel by Anqing Clean Dental Instrument Technology Co., Ltd. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2025
Date Received
May 31, 2024
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 for product code FRG

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  • 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)
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  • K240438 — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (4 (November 4, 2024)