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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mandibular Fixator And/Or Distractor
510(k) Number K983809
Device Name KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
Applicant
KLS-Martin L.P.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ED RANSOM
Correspondent
KLS-Martin L.P.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ED RANSOM
Regulation Number872.4760
Classification Product Code
MQN  
Date Received10/28/1998
Decision Date 01/26/1999
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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