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510(k) K973076

EUROMEDICAL HAEMATURIA FOLEY CATHETER by Unomedical Sdn Bhd — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1998
Date Received
August 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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