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510(k) K901738

SELFCATH by Vitaid, Ltd. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1990
Date Received
April 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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