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FDA 510(k)

V.A.C. GRANUFOAM SILVER PROTECTION DRESSING

K-Number: K050261 · 2005-05-26

ApplicantKinetic Concepts, Inc.
Decision Date2005-05-26
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V.A.C. GRANUFOAM SILVER PROTECTION DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 2005-05-26 under 510(k) number K050261. 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 V.A.C. GRANUFOAM SILVER PROTECTION DRESSING?

V.A.C. GRANUFOAM SILVER PROTECTION DRESSING is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K050261.

When did V.A.C. GRANUFOAM SILVER PROTECTION DRESSING receive FDA 510(k) clearance?

V.A.C. GRANUFOAM SILVER PROTECTION DRESSING received FDA 510(k) clearance on 2005-05-26, under 510(k) number K050261.

Who is the listed applicant for V.A.C. GRANUFOAM SILVER PROTECTION DRESSING?

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

What is the FDA product code for V.A.C. GRANUFOAM SILVER PROTECTION DRESSING?

The FDA product code for V.A.C. GRANUFOAM SILVER PROTECTION DRESSING is OMP.

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Other records listing Kinetic Concepts, Inc. as applicant

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.

K041642V.A.C. GRANUFOAM SILVER DRESSINGK032310MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATSK022011V.A.C. ABDOMINAL DRESSINGK021500VACUUM ASSISTED CLOSUREK021501V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMATK020781WET CHAMBER

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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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