NOVOFINE 31 DISPOSABLE NEEDLE


codes

Device Classification Name needle, hypodermic, single lumen
510(k) Number K002403
Device Name NOVOFINE 31 DISPOSABLE NEEDLE
Original Applicant
NOVO NORODISK PHARMACEUTICALS, INC.
100 overlook center suite 200
princeton,
NJ
08540 -7810

 

Original Contactmichael barbushRegulation Number880.5570Classification Product Code

FMI

Date Received08/07/2000Decision Date12/08/2000Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

TypeTraditionalReviewed by Third PartyNoCombination Product

No