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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 K944007
Device Name EUROPHILIC SLIPPERY COATED FOLEY CATHETER
Applicant
Baxter Healthcare Corp
27636 Ave. Scott
Suite B
Velencia,  CA  91355
Applicant Contact KAM H LEUNG
Correspondent
Baxter Healthcare Corp
27636 Ave. Scott
Suite B
Velencia,  CA  91355
Correspondent Contact KAM H LEUNG
Regulation Number876.5130
Classification Product Code
EZL  
Date Received08/16/1994
Decision Date 06/29/1995
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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