WELLGRAFT PE I


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072444
Device Name WELLGRAFT PE I
Applicant
GWOWEI TECHNOLOGY CO., LTD.
2904 n. boldt drive
flagstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
GWOWEI TECHNOLOGY CO., LTD.
2904 n. boldt drive
flagstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 08/06/2007
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No