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510(k) K813494

WATERS ILEAL RESERVOIR CATHETER by Waters Instruments, Inc. — Product Code KPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 14, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Rectal For Continent Ileostomy
Device Class
Class I
Regulation Number
876.5030
Review Panel
GU
Submission Type

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