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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Condyle, Mandibular, Temporary
510(k) Number K990667
Device Name KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
Applicant
KLS-MARTIN L.P.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Applicant Contact ARTHUR J WARD
Correspondent
KLS-MARTIN L.P.
3234 ELLA LN.
NEW PORT RICHEY,  FL  34655
Correspondent Contact ARTHUR J WARD
Regulation Number872.4770
Classification Product Code
NEI  
Date Received03/02/1999
Decision Date 07/27/2001
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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