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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, semi-constrained, metal/polymer cemented
510(k) Number K120374
Device Name SEVIIN REVERSE SHOULDER
Original Applicant
INGEN ORTHOPEDICS LLC
2650 us highway 130
cranbury,  NJ  08512
Original Contact perry geremakis
Regulation Number888.3660
Classification Product Code
KWS  
Date Received02/06/2012
Decision Date 07/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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