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FDA 510(k)

DEXTEX II STERILIZATION WRAP

K-Number: K800123 · 1980-02-13

ApplicantAhlstrom Dexter
Decision Date1980-02-13
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DEXTEX II STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Ahlstrom Dexter. It received FDA 510(k) clearance on 1980-02-13 under 510(k) number K800123. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXTEX II STERILIZATION WRAP?

DEXTEX II STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is Ahlstrom Dexter. The 510(k) number is K800123.

When did DEXTEX II STERILIZATION WRAP receive FDA 510(k) clearance?

DEXTEX II STERILIZATION WRAP received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800123.

Who is the listed applicant for DEXTEX II STERILIZATION WRAP?

The FDA 510(k) record lists Ahlstrom Dexter as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXTEX II STERILIZATION WRAP?

The FDA product code for DEXTEX II STERILIZATION WRAP is FRG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ahlstrom Dexter as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K933550HYDRASPUN M STERILIZATION WRAPK893764STERILIZATION TRAY LINER

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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