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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pouch, Colostomy
510(k) Number K922401
Device Name 4 SURE TM COLOSTOMY POUCH
Applicant
BOSTON PACIFIC MEDICAL, INC.
636 BEACON ST.
UNIT 204
BOSTON,  MA  02215
Applicant Contact RANDALL GREEN
Correspondent
BOSTON PACIFIC MEDICAL, INC.
636 BEACON ST.
UNIT 204
BOSTON,  MA  02215
Correspondent Contact RANDALL GREEN
Regulation Number876.5900
Classification Product Code
EZQ  
Date Received05/21/1992
Decision Date 06/10/1992
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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