K-L-W INTRAORAL DISTRACTOR


Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K991875
Device Name K-L-W INTRAORAL DISTRACTOR
Applicant
KLS-MARTIN L.P.
3234 ella ln.
new port richey, 
FL 
34655

Applicant Contact ed ransom
Correspondent
KLS-MARTIN L.P.
3234 ella ln.
new port richey, 
FL 
34655

Correspodent Contact ed ransom
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 06/02/1999
Decision Date 08/18/1999
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Dental

510k Review Panel

Dental
summary

summary

Type Traditional
Reviewed by Third Party No
Combination Product

No