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FDA 510(k)

VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100

K-Number: K091585 · 2009-12-29

ApplicantKci USA, Inc.
Decision Date2009-12-29
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 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 2009-12-29 under 510(k) number K091585. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100?

VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 is a medical device that received FDA 510(k) clearance on 2009-12-29. The listed applicant is Kci USA, Inc.. The 510(k) number is K091585.

When did VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 receive FDA 510(k) clearance?

VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 received FDA 510(k) clearance on 2009-12-29, under 510(k) number K091585.

Who is the listed applicant for VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100?

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 VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100?

The FDA product code for VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 is OMP.

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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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