DURAGEN XS DURAL REGENERATION MATRIX


Device Classification Name

dura substitute

510(k) Number K072207
Device Name DURAGEN XS DURAL REGENERATION MATRIX
Applicant
INTEGRA LIFESCIENCES CORP.
311c enterprise drive
plainsboro, 
NJ 
08536

Applicant Contact peter allan
Correspondent
INTEGRA LIFESCIENCES CORP.
311c enterprise drive
plainsboro, 
NJ 
08536

Correspodent Contact peter allan
Regulation Number 882.5910
Classification Product Code
GXQ  
Date Received 08/08/2007
Decision Date 08/23/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls