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FDA 510(k)

ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)

Número K: K163529 · 2017-03-29

RequerenteAvery Dennison Corporation
Data da decisão2017-03-29
Código do produtoFRO
DecisãoSubstantially Equivalent

Resumo do dispositivo

ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Corporation. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K163529. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)?

ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is Avery Dennison Corporation. The 510(k) number is K163529.

When did ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) receive FDA 510(k) clearance?

ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) received FDA 510(k) clearance on 2017-03-29, under 510(k) number K163529.

Who is the listed applicant for ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)?

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

What is the FDA product code for ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)?

The FDA product code for ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) is FRO. This falls under the Anesthesiology category.

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