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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K073331
Device Name DVO EXTENDED ARTICULATION HUMERAL HEADS
Applicant
Dvo Extremity Solutions, LLC
720 E Winona Ave.
Warsaw,  IN  46580
Applicant Contact JEFF ONDRLA
Correspondent
Dvo Extremity Solutions, LLC
720 E Winona Ave.
Warsaw,  IN  46580
Correspondent Contact JEFF ONDRLA
Regulation Number888.3690
Classification Product Code
HSD  
Date Received11/27/2007
Decision Date 02/19/2008
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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