FDA.reportPublic FDA data

510(k) K010359

Device
INNOVO
Applicant
Novo Nordisk A/S
510(k) number
K010359
Product code
FMF
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-14
Date received
2001-02-06
Regulation
880.5860
Classification name
Syringe, Piston
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT FISCHER
Address
100 College Rd. W. Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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