FDA.report

510(k) K842829

Device
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
Applicant
NORTH AMERICAN INSTRUMENT CORP.
510(k) number
K842829
Product code
DTL  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-18
Date received
1984-07-20
Regulation
870.4290
Classification name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
PHILLIP H MORSE
Address
Medical Products Div Hudson Falls NY US 12839 12839

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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Legacy Summary

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FDA Review

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