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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, irrigation, urological
510(k) Number K960787
Device Name TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
Applicant
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Applicant Contact MARY-ELLEN SAYDER
Correspondent
BAXTER HEALTHCARE CORP.
RT. 120 & WILSON RD.
ROUND LAKE,  IL  60073
Correspondent Contact MARY-ELLEN SAYDER
Regulation Number876.5130
Classification Product Code
LJH  
Subsequent Product Code
HRX  
Date Received02/26/1996
Decision Date 05/14/1996
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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