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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name irrigator, ostomy
510(k) Number K871791
Device Name BLOXOM IRRIGATOR
Applicant
I.B. BLOXOM C/O HOGAN & HARTSON
COLUMBIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
I.B. BLOXOM C/O HOGAN & HARTSON
COLUMBIA SQUARE
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.5895
Classification Product Code
EXD  
Date Received05/07/1987
Decision Date 05/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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