FDA.report

510(k) K884408

Device
NAMIC DUAL BACKCHECK VALVE
Applicant
NORTH AMERICAN INSTRUMENT CORP.
510(k) number
K884408
Product code
DTL  
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-12
Date received
1988-10-19
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
ROBERT E FRANKLIN
Address
Glens Falls NY US 12801 12801

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
20193489058939NAMICMEDLINE INDUSTRIES, INC.2021-07-26
H965640009251NAMICNAVILYST MEDICAL, INC.2016-09-20

Legacy Summary

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FDA Review

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