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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 K994154
Device Name MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
Applicant
KLS-Martin L.P.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ARTHUR WARD
Correspondent
KLS-Martin L.P.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ARTHUR WARD
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/09/1999
Decision Date 02/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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