FDA 510(k)

PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM

K-Number: K090848 · 2009-06-17

ApplicantPremier Brands of America, Inc.

Decision Date2009-06-17

Product CodeFQH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM is the device name listed in this FDA 510(k) record. The listed applicant is Premier Brands of America, Inc.. It received FDA 510(k) clearance on 2009-06-17 under 510(k) number K090848. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM?

PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM is a medical device that received FDA 510(k) clearance on 2009-06-17. The listed applicant is Premier Brands of America, Inc.. The 510(k) number is K090848.

When did PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM receive FDA 510(k) clearance?

PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM received FDA 510(k) clearance on 2009-06-17, under 510(k) number K090848.

Who is the listed applicant for PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM?

The FDA 510(k) record lists Premier Brands of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM?

The FDA product code for PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM is FQH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.