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FDA 510(k)

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing

K-Number: K182680 · 2018-12-06

ApplicantExciton Technologies, Inc.
Decision Date2018-12-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing is a medical device manufactured by Exciton Technologies, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K182680. 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 KerraContact Ag Perf Advanced Perforated Silver Wound Dressing?

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Exciton Technologies, Inc.. The 510(k) number is K182680.

When was KerraContact Ag Perf Advanced Perforated Silver Wound Dressing approved by the FDA?

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing received FDA 510(k) clearance on 2018-12-06, under approval number K182680.

What company makes KerraContact Ag Perf Advanced Perforated Silver Wound Dressing?

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing is manufactured by Exciton Technologies, Inc..

What is the FDA product code for KerraContact Ag Perf Advanced Perforated Silver Wound Dressing?

The FDA product code for KerraContact Ag Perf Advanced Perforated Silver Wound Dressing is FRO. This falls under the Anesthesiology category.

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Other Devices by Exciton Technologies, Inc.

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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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