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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K141165
Device Name MATRIXWAVE MMF SYSTEM
Applicant
SYNTHES (USA) PRODUCTS LLC
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact Damon Lees
Correspondent
SYNTHES (USA) PRODUCTS LLC
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact Damon Lees
Regulation Number872.4760
Classification Product Code
JEY  
Date Received05/06/2014
Decision Date 10/17/2014
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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