FDA.report

510(k) K002786

Device
BIOSENSORS CENTRAL VENOUS CATHETER KITS
Applicant
SUNSCOPE INTL., INC.
510(k) number
K002786
Product code
FOZ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-17
Date received
2000-09-07
Regulation
880.5200
Classification name
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JORGE HAIDER
Address
20250 Acacia St., Suite 115 Newport Beach CA US 92660 92660

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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