LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20

Pump, Portable, Aspiration (manual Or Powered)

LAERDAL MEDICAL A/S

The following data is part of a premarket notification filed by Laerdal Medical A/s with the FDA for Laerdal Suction Unit,(4000) Model 78 00 20.

Pre-market Notification Details

Device IDK993668
510k NumberK993668
Device Name:LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
ClassificationPump, Portable, Aspiration (manual Or Powered)
Applicant LAERDAL MEDICAL A/S TANKE SVILANDSGT. 30 Stavanger,  NO N 4001
ContactMagne Steinset
CorrespondentMagne Steinset
LAERDAL MEDICAL A/S TANKE SVILANDSGT. 30 Stavanger,  NO N 4001
Product CodeBTA  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-01
Decision Date1999-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07045432030839 K993668 000
07045432030822 K993668 000
07045430042094 K993668 000
07045430042087 K993668 000

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