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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 K971643
Device Name RUSCH BRILLANT BALLOON CATHETER
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact JAMES R WHITNEY
Correspondent
RUSCH INTL.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact JAMES R WHITNEY
Regulation Number876.5130
Classification Product Code
EZL  
Date Received05/05/1997
Decision Date 10/07/1997
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
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