510(k) K961147

CLOSED FLUID COLLECTION SYSTEM by B.Braun Medical, Inc. — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1996
Date Received
March 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type