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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 K080458
Device Name MIS CREST WIDENER
Applicant
MIS - IMPLANT TECHNOLOGIES LTD.
POB 110
SHLOMI INDUSTRIAL ZONE
SHLOMI,  IL 22832
Applicant Contact IMAN KHORSHID
Correspondent
MIS - IMPLANT TECHNOLOGIES LTD.
POB 110
SHLOMI INDUSTRIAL ZONE
SHLOMI,  IL 22832
Correspondent Contact IMAN KHORSHID
Regulation Number872.4760
Classification Product Code
MQN  
Date Received02/20/2008
Decision Date 12/17/2008
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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