COLLACARE DENTAL


Device Classification Name

dressing, wound, collagen

510(k) Number K110388
Device Name COLLACARE DENTAL
Applicant
INNOCOLL PHARMACEUTICALS LTD
midlands research and
innovation centre, dublin rd.
athlone, co. westmeath, 

IE

ei

Applicant Contact aaron wyse
Correspondent
INNOCOLL PHARMACEUTICALS LTD
midlands research and
innovation centre, dublin rd.
athlone, co. westmeath, 

IE

ei

Correspodent Contact aaron wyse
Classification Product Code
KGN  
Date Received 02/10/2011
Decision Date 08/09/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No