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510(k) K251178

Ready to use Nelaton Catheter by Jamjoom Fullcare Corporation — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2026
Date Received
April 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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