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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K042066
Device Name KLSA MARTIN HAND DISTRACTOR
Applicant
KLS-Martin L.P.
1239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-Martin L.P.
1239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number888.3040
Classification Product Code
JEC  
Date Received08/02/2004
Decision Date 08/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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