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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K881781
Device Name CATHETER STRAP
Applicant
BAXTER HEALTHCARE CORP.
ONE BAXTER PKWY.
DEERFIELD,  IL  60015
Applicant Contact BETSY A BROWN
Correspondent
BAXTER HEALTHCARE CORP.
ONE BAXTER PKWY.
DEERFIELD,  IL  60015
Correspondent Contact BETSY A BROWN
Regulation Number876.5130
Classification Product Code
KOD  
Date Received04/26/1988
Decision Date 08/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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