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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 K854173
Device Name UCD URINE SPECIMEN COLLECTOR
Applicant
Baker Instructions Corp.
100 Cascade Dr.
P.O. Box 2168
Allentown,  PA  18001
Applicant Contact TOMALESKY
Correspondent
Baker Instructions Corp.
100 Cascade Dr.
P.O. Box 2168
Allentown,  PA  18001
Correspondent Contact TOMALESKY
Regulation Number876.5250
Classification Product Code
KNX  
Date Received10/15/1985
Decision Date 11/04/1985
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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