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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
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