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FDA 510(k)

STERISURE STERILIZATION WRAP

K-Number: K944854 · 1994-12-19

ApplicantFiberweb North America, Inc.
Decision Date1994-12-19
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERISURE STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Fiberweb North America, Inc.. It received FDA 510(k) clearance on 1994-12-19 under 510(k) number K944854. 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 STERISURE STERILIZATION WRAP?

STERISURE STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 1994-12-19. The listed applicant is Fiberweb North America, Inc.. The 510(k) number is K944854.

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

STERISURE STERILIZATION WRAP received FDA 510(k) clearance on 1994-12-19, under 510(k) number K944854.

Who is the listed applicant for STERISURE STERILIZATION WRAP?

The FDA 510(k) record lists Fiberweb North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERISURE STERILIZATION WRAP?

The FDA product code for STERISURE STERILIZATION WRAP is FRG.

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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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