FDA 510(k)

Dakin's Skin and Wound Cleanser

Numéro K : K150208 · 2016-07-21

Date de décision2016-07-21

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

Dakin's Skin and Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Century Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K150208. 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.

Questions fréquentes

What is the Dakin's Skin and Wound Cleanser?

Dakin's Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Century Pharmaceuticals, Inc.. The 510(k) number is K150208.

When did Dakin's Skin and Wound Cleanser receive FDA 510(k) clearance?

Dakin's Skin and Wound Cleanser received FDA 510(k) clearance on 2016-07-21, under 510(k) number K150208.

Who is the listed applicant for Dakin's Skin and Wound Cleanser?

The FDA 510(k) record lists Century Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dakin's Skin and Wound Cleanser?

The FDA product code for Dakin's Skin and Wound Cleanser is FRO. This falls under the Anesthesiology category.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositifs connexes (Code : FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.