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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 K110214
Device Name DIRECTVISION CATHETER, UNCOATED
Applicant
Percuvision
200 Homer Ave., 2nd Floor
Ashland,  MA  01721
Applicant Contact FIDES MALDONADO
Correspondent
Percuvision
200 Homer Ave., 2nd Floor
Ashland,  MA  01721
Correspondent Contact FIDES MALDONADO
Regulation Number876.5130
Classification Product Code
EZL  
Date Received01/25/2011
Decision Date 05/27/2011
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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