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510(k) K141642

VAPRO INTERMITTENT CATHETER by Hollister Incorporated — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2014
Date Received
June 19, 2014
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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