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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 K162356
Device Name Vesair Cystoscopic Sheath
Applicant
Solace Therapeutics
135 Newbury St
Framingham,  MA  01701
Applicant Contact William Gruber
Correspondent
Solace Therapeutics
135 Newbury St
Framingham,  MA  01701
Correspondent Contact William Gruber
Regulation Number876.5130
Classification Product Code
KNY  
Date Received08/23/2016
Decision Date 03/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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