FDA.report

510(k) K082110

Device
DUAL SYRINGE HOLDER
Applicant
Surgin Surgical Instrumentation, Inc.
510(k) number
K082110
Product code
FMG
Decision
Substantially Equivalent (SESE)
Decision date
2009-06-17
Date received
2008-07-28
Regulation
880.5440
Classification name
Stopcock, I.V. Set
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GRACE HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

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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