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FDA 510(k)

PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH

K-Number: K915358 · 1992-04-28

ApplicantMedtronic Vascular
Decision Date1992-04-28
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1992-04-28 under 510(k) number K915358. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH?

PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH is a medical device that received FDA 510(k) clearance on 1992-04-28. The listed applicant is Medtronic Vascular. The 510(k) number is K915358.

When did PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH receive FDA 510(k) clearance?

PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH received FDA 510(k) clearance on 1992-04-28, under 510(k) number K915358.

Who is the listed applicant for PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH?

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

What is the FDA product code for PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH?

The FDA product code for PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH is KGX.

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Related Devices (Code: KGX)

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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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