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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 K872824
Device Name P. URINE METER, 250CC
Applicant
Ni-Med, Inc.
12624 W. 10 Mile Rd.
South Lyon,  MI  48178
Applicant Contact HOWARD MEADE
Correspondent
Ni-Med, Inc.
12624 W. 10 Mile Rd.
South Lyon,  MI  48178
Correspondent Contact HOWARD MEADE
Regulation Number876.5250
Classification Product Code
KNX  
Date Received07/16/1987
Decision Date 10/14/1987
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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