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FDA 510(k)

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

N.º K: K152669 · 2016-01-15

SolicitantePms Tip Teknolojileri Sanayi VE Ticaret Limited Std
Fecha de decisión2016-01-15
Código de productoFRG
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Dispositivos relacionados (Código: FRG)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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