MODIFIED STERILE DISPOSABLE STOPCOCKS

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

COBE LABORATORIES, INC.

The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Modified Sterile Disposable Stopcocks.

Pre-market Notification Details

Device IDK781579
510k NumberK781579
Device Name:MODIFIED STERILE DISPOSABLE STOPCOCKS
ClassificationAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTL  
CFR Regulation Number870.4290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-15
Decision Date1978-10-05

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