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510(k) K871791

BLOXOM IRRIGATOR by I.B. Bloxom C/O Hogan & Hartson — Product Code EXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1987
Date Received
May 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Ostomy
Device Class
Class II
Regulation Number
876.5895
Review Panel
GU
Submission Type

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