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510(k) K181957

Device
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
Applicant
Tianchang Jiarui Packaging Material Co., Ltd.
510(k) number
K181957
Product code
FRG  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-09
Date received
2018-07-23
Regulation
880.6850
Classification name
Wrap, Sterilization
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Zhang Ruiqing
Address
Yeshan Industria Zone Tianchang CN 239300 239300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FRG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252823Dukal Crepe Paper Sterilization WrapDukal, LLC2026-05-28
K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.2026-05-18
K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.2026-01-28
K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.2025-12-12
K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.2025-10-31
K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.2025-06-26
K250321GCI Sterilization WrappersGeorge Courey, Inc.2025-06-06
K243721Self Sealing Sterilization PouchesWellmed Dental Medical Supply Co., Ltd.2025-04-25
K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)Turbett Surgical2025-04-04
K241565Sterilization Package/ReelAnqing Clean Dental Instrument Technology Co., Ltd.2025-02-24
K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.2025-02-21
K242898Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd.2025-02-21
K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)Comercializadora Brever2024-11-04
K242839Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co. , Ltd.2024-10-16
K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.2024-10-07

Legacy Summary#

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FDA Review#

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