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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 K130635
Device Name SEVIIN SURFACE REPLACEMENT SHOULDER
Applicant
Ingen Orthopedics, LLC
2650 Us Hwy. 130
Cranbury,  NJ  08512
Applicant Contact PERRY A GEREMAKIS
Correspondent
Ingen Orthopedics, LLC
2650 Us Hwy. 130
Cranbury,  NJ  08512
Correspondent Contact PERRY A GEREMAKIS
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Codes
KWS   KWT  
Date Received03/11/2013
Decision Date 08/26/2013
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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