MIS CREST WIDENER


Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K080458
Device Name MIS CREST WIDENER
Applicant
MIS – IMPLANT TECHNOLOGIES LTD.
pob 110
shlomi industrial zone
shlomi, 

IL

22832

Applicant Contact iman khorshid
Correspondent
MIS – IMPLANT TECHNOLOGIES LTD.
pob 110
shlomi industrial zone
shlomi, 

IL

22832

Correspodent Contact iman khorshid
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 02/20/2008
Decision Date 12/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No