Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SILVERLON DIRECT PRESSURE WOUND DRESSING

K-Number: K984207 · 2007-03-19

ApplicantArgentum International, LLC
Decision Date2007-03-19
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SILVERLON DIRECT PRESSURE WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Argentum International, LLC. It received FDA 510(k) clearance on 2007-03-19 under 510(k) number K984207. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILVERLON DIRECT PRESSURE WOUND DRESSING?

SILVERLON DIRECT PRESSURE WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2007-03-19. The listed applicant is Argentum International, LLC. The 510(k) number is K984207.

When did SILVERLON DIRECT PRESSURE WOUND DRESSING receive FDA 510(k) clearance?

SILVERLON DIRECT PRESSURE WOUND DRESSING received FDA 510(k) clearance on 2007-03-19, under 510(k) number K984207.

Who is the listed applicant for SILVERLON DIRECT PRESSURE WOUND DRESSING?

The FDA 510(k) record lists Argentum International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVERLON DIRECT PRESSURE WOUND DRESSING?

The FDA product code for SILVERLON DIRECT PRESSURE WOUND DRESSING is KMF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Argentum International, LLC 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.

K984204SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIPK984205SILVERLON ADHESIVE STRIPK023612SILVERLON CONTACT WOUND DRESSINGK023609SILVERLON ADHESIVE STRIPK984210SILVERLON WOUND PACKING STRIPSK984208SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD

View all 8 devices →

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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.

↑