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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty
510(k) Number K141591
Device Name SMARTGRAFT 30 SYSTEM
Applicant
Ingeneron, Inc.
8205 El Rio
Houston,  TX  77054
Applicant Contact ANITA KADALA
Correspondent
Ingeneron, Inc.
8205 El Rio
Houston,  TX  77054
Correspondent Contact ANITA KADALA
Regulation Number878.5040
Classification Product Code
MUU  
Date Received06/13/2014
Decision Date 09/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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