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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 K890550
Device Name CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)
Applicant
Consolidated Products & Services, Inc.
30 Fayette St.
North Quincy,  MA  02171
Applicant Contact RICHARD MCMANUS
Correspondent
Consolidated Products & Services, Inc.
30 Fayette St.
North Quincy,  MA  02171
Correspondent Contact RICHARD MCMANUS
Regulation Number876.5250
Classification Product Code
KNX  
Date Received02/06/1989
Decision Date 02/28/1989
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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