GUARDIAN URETHRAL SHEATH

Accessories, Catheter, G-u

SOLACE THERAPEUTICS

The following data is part of a premarket notification filed by Solace Therapeutics with the FDA for Guardian Urethral Sheath.

Pre-market Notification Details

Device IDK131803
510k NumberK131803
Device Name:GUARDIAN URETHRAL SHEATH
ClassificationAccessories, Catheter, G-u
Applicant SOLACE THERAPEUTICS 135 NEWBURY ST Framingham,  MA  01701
ContactWilliam Gruber
CorrespondentWilliam Gruber
SOLACE THERAPEUTICS 135 NEWBURY ST Framingham,  MA  01701
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-19
Decision Date2013-08-20
Summary:summary

Trademark Results [GUARDIAN URETHRAL SHEATH]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GUARDIAN URETHRAL SHEATH
GUARDIAN URETHRAL SHEATH
86238493 4624978 Live/Registered
Solace Therapeutics, Inc.
2014-04-01

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