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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)

K-Number: K163529 · 2017-03-29

ApplicantAvery Dennison Corporation
Decision Date2017-03-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) is a medical device manufactured by Avery Dennison Corporation. It received FDA 510(k) clearance on 2017-03-29 under approval 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.

Frequently Asked Questions

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. It is manufactured by Avery Dennison Corporation. The 510(k) number is K163529.

When was ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) approved by the FDA?

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 approval number K163529.

What company makes 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 manufactured by Avery Dennison Corporation.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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