BIO-MEDICUS TUBING CONNECTORS

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

BIO MEDICUS, INC.

The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-medicus Tubing Connectors.

Pre-market Notification Details

Device IDK883956
510k NumberK883956
Device Name:BIO-MEDICUS TUBING CONNECTORS
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
ContactJohn R Dalpee
CorrespondentJohn R Dalpee
BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-19
Decision Date1988-10-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20673978555267 K883956 000
20673978555182 K883956 000
20673978555199 K883956 000
20673978555205 K883956 000
20673978555229 K883956 000
20673978555236 K883956 000
20673978555243 K883956 000
20673978555250 K883956 000
20673978555274 K883956 000
20673978555281 K883956 000
20673978555311 K883956 000
20673978555328 K883956 000
20673978555335 K883956 000
20673978555342 K883956 000
20673978555175 K883956 000

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