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FDA 510(k)

DISPOSABLE STERILIZATION WRAP

K-Number: K811242 · 1981-05-21

ApplicantAmsco Co.
Decision Date1981-05-21
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Co.. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K811242. 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 DISPOSABLE STERILIZATION WRAP?

DISPOSABLE STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Amsco Co.. The 510(k) number is K811242.

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

DISPOSABLE STERILIZATION WRAP received FDA 510(k) clearance on 1981-05-21, under 510(k) number K811242.

Who is the listed applicant for DISPOSABLE STERILIZATION WRAP?

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

What is the FDA product code for DISPOSABLE STERILIZATION WRAP?

The FDA product code for DISPOSABLE STERILIZATION WRAP is FRG.

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Other records listing Amsco Co. 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.

K912471EAGLE 3000 SDSK854922AMSCO POLARIS SLK833187HALL OSTEONK832945EAGLE 2000 STERILIZER SERIES GAS/AERAK832187HALL OSCILLATORK832186HALL DRILL/REAMER

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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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