ADDITIVE HINGE CAP

Container, I.v.

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Additive Hinge Cap.

Pre-market Notification Details

Device IDK791796
510k NumberK791796
Device Name:ADDITIVE HINGE CAP
ClassificationContainer, I.v.
Applicant ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-09-14
Decision Date1979-10-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20887709123643 K791796 000

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