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FDA 510(k)

PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH

K-Number: K915357 · 1992-05-28

ApplicantMedtronic Vascular
Decision Date1992-05-28
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROMEON HYDROGEL DRESSING #45 STERILE W/O 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 1992-05-28 under 510(k) number K915357. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Medtronic Vascular. The 510(k) number is K915357.

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

PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH received FDA 510(k) clearance on 1992-05-28, under 510(k) number K915357.

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

The FDA product code for PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH is NAE.

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Other records listing Medtronic Vascular as applicant

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Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K073246ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical Products

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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