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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lock, Wire, And Ligature, Intraoral
510(k) Number K061271
Device Name ERCH ARCH BAR, MODEL 38-690-00
Applicant
KLS-Martin L.P.
11239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-Martin L.P.
11239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number872.4600
Classification Product Code
DYX  
Date Received05/05/2006
Decision Date 06/30/2006
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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