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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 K863671
Device Name PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5
Applicant
Samco Industries, Inc.
P.O. Box 648
Stoughton,  MA  02072
Applicant Contact DAVID S LOCKE
Correspondent
Samco Industries, Inc.
P.O. Box 648
Stoughton,  MA  02072
Correspondent Contact DAVID S LOCKE
Regulation Number876.5250
Classification Product Code
KNX  
Date Received09/19/1986
Decision Date 10/03/1986
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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