Q220F CARDITOMY RESERVOIR/MODIFIED

Reservoir, Blood, Cardiopulmonary Bypass

BENTLEY LABORATORIES, INC.

The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Q220f Carditomy Reservoir/modified.

Pre-market Notification Details

Device IDK790635
510k NumberK790635
Device Name:Q220F CARDITOMY RESERVOIR/MODIFIED
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-02
Decision Date1979-04-18

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