FDA 510(k)

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

K-Nummer: K160755 · 2016-07-27

Entscheidungsdatum2016-07-27

ProduktcodeFRG

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Ahlstrom Nonwovens, LLC. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K160755. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Ahlstrom Nonwovens, LLC. The 510(k) number is K160755.

When did Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap receive FDA 510(k) clearance?

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160755.

Who is the listed applicant for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

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

What is the FDA product code for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap?

The FDA product code for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap is FRG.

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Weitere Einträge mit Ahlstrom Nonwovens, LLC als Antragsteller

K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

Verwandte Geräte (Code: FRG)

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 SterilisationsfolieDukal, LLC K253454HALYARD* 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 Sterilisationsbeutel und RöhrchenPropper Manufacturing Co., Inc.

Offizielle Quelle

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