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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K120374
Device Name SEVIIN REVERSE SHOULDER
Applicant
Ingen Orthopedics, LLC
2650 Us Highway 130
Cranbury,  NJ  08512
Applicant Contact PERRY GEREMAKIS
Correspondent
Ingen Orthopedics, LLC
2650 Us Highway 130
Cranbury,  NJ  08512
Correspondent Contact PERRY GEREMAKIS
Regulation Number888.3660
Classification Product Code
PHX  
Date Received02/06/2012
Decision Date 07/09/2012
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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