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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Urine Collection, Leg, For External Use, Sterile
510(k) Number K896728
Device Name 4 SURE URINARY LEG BAG
Applicant
The Boston & Pacific Co., Inc.
34 Brewster Rd.
Hingham,  MA  02043
Applicant Contact ORTIZ
Correspondent
The Boston & Pacific Co., Inc.
34 Brewster Rd.
Hingham,  MA  02043
Correspondent Contact ORTIZ
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received11/29/1989
Decision Date 02/20/1990
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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