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FDA 510(k)

EXSUDEX WOUND DRAINAGE PUMP

K-Number: K082311 · 2008-10-08

ApplicantThe Medical Company
Decision Date2008-10-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXSUDEX WOUND DRAINAGE PUMP is the device name listed in this FDA 510(k) record. The listed applicant is The Medical Company. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K082311. 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 EXSUDEX WOUND DRAINAGE PUMP?

EXSUDEX WOUND DRAINAGE PUMP is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is The Medical Company. The 510(k) number is K082311.

When did EXSUDEX WOUND DRAINAGE PUMP receive FDA 510(k) clearance?

EXSUDEX WOUND DRAINAGE PUMP received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082311.

Who is the listed applicant for EXSUDEX WOUND DRAINAGE PUMP?

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

What is the FDA product code for EXSUDEX WOUND DRAINAGE PUMP?

The FDA product code for EXSUDEX WOUND DRAINAGE PUMP is OMP.

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Related Devices (Code: OMP)

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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