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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 K042261
Device Name MACROPORE PURICEL LIPOPLASTY SYSTEM
Applicant
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Applicant Contact KENNETH K KLEINHENZ
Correspondent
MACROPORE BIOSURGERY, INC.
6740 TOP GUN ST.
SAN DIEGO,  CA  92121
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number878.5040
Classification Product Code
QPB  
Date Received08/23/2004
Decision Date 09/20/2004
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
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