C-LEG (3C100)


Device Classification Name

assembly, knee/shank/ankle/foot, external

510(k) Number K991590
Device Name C-LEG (3C100)
Applicant
OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
3000 xenium lane, suite n
plymouth, 
MN 
55441

Applicant Contact john hendrickson
Correspondent
OTTO BOCK ORTHOPEDIC INDUSTRY, INC.
3000 xenium lane, suite n
plymouth, 
MN 
55441

Correspodent Contact john hendrickson
Regulation Number 890.3500
Classification Product Code
ISW  
Subsequent Product Code
KFX  
Date Received 05/07/1999
Decision Date 07/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls