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FDA 510(k)

ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026

K-Number: K090489 · 2009-05-14

ApplicantKci USA, Inc.
Decision Date2009-05-14
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2009-05-14 under 510(k) number K090489. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026?

ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 is a medical device that received FDA 510(k) clearance on 2009-05-14. The listed applicant is Kci USA, Inc.. The 510(k) number is K090489.

When did ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 receive FDA 510(k) clearance?

ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 received FDA 510(k) clearance on 2009-05-14, under 510(k) number K090489.

Who is the listed applicant for ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026?

The FDA 510(k) record lists Kci USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026?

The FDA product code for ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 is FTL.

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Other records listing Kci USA, Inc. as applicant

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Related Devices (Code: FTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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