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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K141252
Device Name GUARDIAN URETHRAL SHEATH
Applicant
Solace Therapeutics
135 Newbury St.
Farmingham,  MA  01701
Applicant Contact ADAM HEROUX
Correspondent
Solace Therapeutics
135 Newbury St.
Farmingham,  MA  01701
Correspondent Contact ADAM HEROUX
Regulation Number876.5130
Classification Product Code
KNY  
Date Received05/14/2014
Decision Date 06/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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