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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enema Kit
510(k) Number K922398
Device Name 4 SURE TM ENEMA BAG SET
Applicant
Boston Pacific Medical, Inc.
451 D St.
Suite 811
Boston,  MA  02210
Applicant Contact RICHARD A DEROSA
Correspondent
Boston Pacific Medical, Inc.
451 D St.
Suite 811
Boston,  MA  02210
Correspondent Contact RICHARD A DEROSA
Regulation Number876.5210
Classification Product Code
FCE  
Date Received05/21/1992
Decision Date 06/17/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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