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510(k) K192577

Actreen Hi-Lite Intermittent Urinary Catheters by B.Braun Medical, Inc. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2020
Date Received
September 19, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code GBM

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