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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K181346
Device Name CystoSure Plus Catheter
Applicant
Emmy Medical, LLC
18 Hillside Dr.
Holliston,  MA  01746
Applicant Contact Ronald Adams
Correspondent
R&Q Solutions., LLC
15 Standish Rd.
Norfolk,  MA  02056
Correspondent Contact Christine Santagate
Regulation Number876.5130
Classification Product Code
EZL  
Date Received05/21/2018
Decision Date 08/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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