MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

Device Classification Name

cement, bone, vertebroplasty

510(k) Number K071375
Device Name MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
Applicant
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
555 thirteenth street, nw
washington, 
DC 
20004

Applicant Contact jonathan s kahan
Correspondent
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
555 thirteenth street, nw
washington, 
DC 
20004

Correspodent Contact jonathan s kahan
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Code
OAR  
Date Received 05/16/2007
Decision Date 12/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No