ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15


definition

Device Classification Name

external mandibular fixator and/or distractor

510(k) Number K000580
Device Name ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
Original Applicant
KLS-MARTIN L.P.
3234 ella ln.
new port richey, 
FL 
34655

Original Contact art ward
Regulation Number 872.4760
Classification Product Code
MQN  
Date Received 02/22/2000
Decision Date 07/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No