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FDA 510(k)

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)

K-Number: K180570 · 2019-01-14

ApplicantArgentum Medical, LLC
Decision Date2019-01-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) is a medical device manufactured by Argentum Medical, LLC. It received FDA 510(k) clearance on 2019-01-14 under approval number K180570. 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 Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)?

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) is a medical device that received FDA 510(k) clearance on 2019-01-14. It is manufactured by Argentum Medical, LLC. The 510(k) number is K180570.

When was Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) approved by the FDA?

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) received FDA 510(k) clearance on 2019-01-14, under approval number K180570.

What company makes Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)?

Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) is manufactured by Argentum Medical, LLC.

What is the FDA product code for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)?

The FDA product code for Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING

Other Devices by Argentum Medical, LLC

K190343Silverlon Wound Contact, Burn Contact Dressings 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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