510(k) K052286

DEUTSCH ANTI-BLOCKAGE WOUND DRAIN by The Catheter Exchange, Inc. — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2005
Date Received
August 22, 2005
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