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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K853892
Device Name VISTA MED-URISTAT
Applicant
Vista Med
Summerall Center
19 Hagood Ave. #103
Charleston,  SC  29403
Applicant Contact JAY F SCHAEFER
Correspondent
Vista Med
Summerall Center
19 Hagood Ave. #103
Charleston,  SC  29403
Correspondent Contact JAY F SCHAEFER
Regulation Number876.5250
Classification Product Code
KNX  
Date Received09/19/1985
Decision Date 12/02/1985
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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