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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K003883
Device Name MOLINA ORBITAL MALAR DISTRACTOR
Applicant
KLS-Martin L.P.
11239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Applicant Contact MIKE TEAGUE
Correspondent
KLS-Martin L.P.
11239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Correspondent Contact MIKE TEAGUE
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/15/2000
Decision Date 01/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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