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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
510(k) Number K903816
Device Name URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
Applicant
Respiratory Support Products, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92614
Applicant Contact KERRY J TOMIC
Correspondent
Respiratory Support Products, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92614
Correspondent Contact KERRY J TOMIC
Regulation Number876.5980
Classification Product Code
EZK  
Date Received08/20/1990
Decision Date 10/31/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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