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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K042573
Device Name KLS MARTIN DRILL-FREE MMF SCREW
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 Number872.4880
Classification Product Code
DZL  
Date Received09/21/2004
Decision Date 10/18/2004
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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