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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
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