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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K133941
FOIA Releasable 510(k) K133941
Device Name MITEK ARTHROSCOPES
Applicant
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH Ch 2400
Applicant Contact SUSAN KAGAN
Correspondent
Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle,  CH Ch 2400
Correspondent Contact SUSAN KAGAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/23/2013
Decision Date 04/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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