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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K063275
Device Name DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)
Applicant
TERRAY CORP.
49 JACKSON LANE
PINE GROVE INDUSTRIAL PARK
ARNPRIOR,  CA K7S 3G8
Applicant Contact STEVEN WILLIS
Correspondent
TERRAY CORP.
49 JACKSON LANE
PINE GROVE INDUSTRIAL PARK
ARNPRIOR,  CA K7S 3G8
Correspondent Contact STEVEN WILLIS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/30/2006
Decision Date 07/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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