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510(k) K931202

Device
STERILIZATION WRAP-STERISHEET
Applicant
ARJO WIGGINS MEDICAL, INC.
510(k) number
K931202
Product code
FRG  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-16
Date received
1993-03-09
Regulation
880.6850
Classification name
Wrap, Sterilization
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
R.M.S., INC.
Address
Susan B. Howard P.O. Box 2010 Palm Harbor FL US 34682 34682

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FRG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.2026-07-02
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
K242898Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd.2025-02-21
K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.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

Legacy Summary#

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FDA Review#

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