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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, blood, cardiopulmonary bypass, non-roller type
510(k) Number K170029
Device Name FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
Applicant
INTERNATIONAL BIOPHYSICS CORPORATION
2101 E. ST. ELMO ROAD
AUSTIN,  TX  78744
Applicant Contact Geoff Marcek
Correspondent
INTERNATIONAL BIOPHYSICS CORPORATION
2101 E. ST. ELMO ROAD
AUSTIN,  TX  78744
Correspondent Contact Geoff Marcek
Regulation Number870.4360
Classification Product Code
KFM  
Date Received01/04/2017
Decision Date 12/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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