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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K981203
Device Name RUSCH BLAKEMORE 3 LUMEN, STERILE
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 Number876.5980
Classification Product Code
KNT  
Date Received04/02/1998
Decision Date 06/05/1998
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
Recalls CDRH Recalls
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