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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 K071628
Device Name STRYKER EXTERNAL FIXATION SYSTEM
Applicant
STRYKER CMF
750 TRADE CENTRE WAY
SUITE 200
KALAMAZOO,  MI  49001
Applicant Contact TENNILLE FOLK
Correspondent
STRYKER CMF
750 TRADE CENTRE WAY
SUITE 200
KALAMAZOO,  MI  49001
Correspondent Contact TENNILLE FOLK
Regulation Number872.4760
Classification Product Code
MQN  
Subsequent Product Code
KTT  
Date Received06/14/2007
Decision Date 08/10/2007
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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