FDA 510(k)

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

Номер K: K152669 · 2016-01-15

ЗаявительPms Tip Teknolojileri Sanayi VE Ticaret Limited Std

Дата решения2016-01-15

Код продуктаFRG

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is the device name listed in this FDA 510(k) record. The listed applicant is Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152669. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std. The 510(k) number is K152669.

When did PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) receive FDA 510(k) clearance?

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152669.

Who is the listed applicant for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

The FDA 510(k) record lists Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)?

The FDA product code for PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) is FRG.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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 Sterilization WrapDukal, 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 Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Официальный источник

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