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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 K871042
Device Name URINE METER, 250CC
Applicant
Salt Creek Medical Technologies
5500 Arapaho Pass
Pinckney,  MI  48169
Applicant Contact HOWARD MEADE
Correspondent
Salt Creek Medical Technologies
5500 Arapaho Pass
Pinckney,  MI  48169
Correspondent Contact HOWARD MEADE
Regulation Number876.5250
Classification Product Code
KNX  
Date Received03/17/1987
Decision Date 03/25/1987
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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