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510(k) K111384

LIFEBRIDGE by Lifebridge Medizintechnik AG — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2011
Date Received
May 17, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

Other clearances by Lifebridge Medizintechnik AG

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  • K090006 — LIFEBRIDGE B2T, MODEL 7001 (October 15, 2009)

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