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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 For Removal
510(k) Number K113795
Device Name SUCTION LIPOLASTY ACCESSORIES
Applicant
Norman M. Black Iii
2759 Hawthorne Dr. NE
Atlanta,  GA  30345
Applicant Contact NORMAN BLACK
Correspondent
Norman M. Black Iii
2759 Hawthorne Dr. NE
Atlanta,  GA  30345
Correspondent Contact NORMAN BLACK
Regulation Number878.5040
Classification Product Code
QPB  
Date Received12/23/2011
Decision Date 08/07/2012
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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