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Food law / Traumatology / Medical equipment / Pharmaceuticals policy / Medical device / Federal Food / Drug / and Cosmetic Act / Premarket approval / Wound / Title 21 of the Code of Federal Regulations / Medicine / Health / Food and Drug Administration


510(k) Summary Prepared December 16, 2011 Revised June 26,2012 Sponsor:
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Document Date: 2012-09-10 10:26:05

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File Size: 128,25 KB

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City

Emeryville / Los Altos / /

Company

K113820 Trade / NovaBay Pharmaceuticals Inc. / Wound Cleanser / Vashe Wound Therapy+ Solution / Anacapa Technologies Inc. / Pickering Consulting / NovaBay Pharmceuticals Incorporated / NovalBay Pharmaceuticals Inc. / /

Event

FDA Phase / /

/

IndustryTerm

healthcare professionals / announcements concerning your device / predicate devices / manufacturing practice requirements / Internet address http /

MedicalCondition

cuts / acute and chronic dermal lesions / Stage I-IV pressure ulcers / leg ulcers / stasis ulcers / diabetic foot ulcers / burns / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Division of Srgical / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / Device Evaluation Center for Devices and Radiological Health Enclosure / Mark N. Melkerson Director Division of Surgical / CDRH's office of Surveillance / /

Person

Silver Spring / Mark N. Melkerson / Behzad Khosrovi / /

/

Position

Unclassified General / /

Product

Federal Food / /

ProvinceOrState

Maryland / California / /

Technology

radiation / /

URL

http /

SocialTag