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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, peritoneal, long-term indwelling
510(k) Number K903502
Device Name LIFECOIL CATHETER
Applicant
LIFEMED OF CALIFORNIA
2059 DEL AMO BLVD.
COMPTON,  CA  90220
Applicant Contact PATRICIA BRINKER
Correspondent
LIFEMED OF CALIFORNIA
2059 DEL AMO BLVD.
COMPTON,  CA  90220
Correspondent Contact PATRICIA BRINKER
Regulation Number876.5630
Classification Product Code
FJS  
Date Received08/03/1990
Decision Date 10/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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