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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irrigator, Ostomy
510(k) Number K904586
Device Name PALEX IRRIGATION SET
Applicant
Palex Intl. SA
Carretera De Terrassa, 121
08191 Rubi' (Barcelona)
Spain,  ES
Applicant Contact MARTIN A JORDAN
Correspondent
Palex Intl. SA
Carretera De Terrassa, 121
08191 Rubi' (Barcelona)
Spain,  ES
Correspondent Contact MARTIN A JORDAN
Regulation Number876.5895
Classification Product Code
EXD  
Date Received10/09/1990
Decision Date 12/28/1990
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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