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FDA 510(k)

Silverlon Wound Contact, Burn Contact Dressings

K-Number: K190343 · 2019-07-18

ApplicantArgentum Medical, LLC
Decision Date2019-07-18
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Silverlon Wound Contact, Burn Contact Dressings is a medical device manufactured by Argentum Medical, LLC. It received FDA 510(k) clearance on 2019-07-18 under approval number K190343. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Argentum Medical, LLC. The 510(k) number is K190343.

When was Silverlon Wound Contact, Burn Contact Dressings approved by the FDA?

Silverlon Wound Contact, Burn Contact Dressings received FDA 510(k) clearance on 2019-07-18, under approval number K190343.

What company makes Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is manufactured by Argentum Medical, LLC.

What is the FDA product code for Silverlon Wound Contact, Burn Contact Dressings?

The FDA product code for Silverlon Wound Contact, Burn Contact Dressings is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07040683 Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07573202 Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery NOT_YET_RECRUITING NCT07217613 Prospective Evaluation of Silk Fibroin Incision Dressings in ACL Reconstruction RECRUITING NCT06312267 Reducing Wound Infections Using Bioelectric Wound Dressings ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Argentum Medical, LLC

K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) K241225Silverlon® Wound Contact, Burn Contact Dressing

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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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