PALAMED G


Device Classification Name

bone cement

510(k) Number K050855
Device Name PALAMED G
Applicant
HERAEUS KULZER GMBH
phillip reis-strasse 8/13
wehrheim, 

DE

d-61273

Applicant Contact christian tuchscherer
Correspondent
HERAEUS KULZER GMBH
phillip reis-strasse 8/13
wehrheim, 

DE

d-61273

Correspodent Contact christian tuchscherer
Regulation Number 888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received 04/04/2005
Decision Date 07/07/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes