FDA 510(k)

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

Numéro K : K160595 · 2016-11-18

DemandeurPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti

Date de décision2016-11-18

Code produitFRG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K160595. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti. The 510(k) number is K160595.

When did PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator receive FDA 510(k) clearance?

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator received FDA 510(k) clearance on 2016-11-18, under 510(k) number K160595.

Who is the listed applicant for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

The FDA 510(k) record lists Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator?

The FDA product code for PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator is FRG.

Essais cliniques associés

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Dispositifs connexes (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 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.

Source officielle

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