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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 K032802
Device Name HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
Applicant
Hk Surgical, Inc.
2620a Temple Heights Dr.
Oceanside,  CA  92675
Applicant Contact SALLY M BOWDON
Correspondent
Hk Surgical, Inc.
2620a Temple Heights Dr.
Oceanside,  CA  92675
Correspondent Contact SALLY M BOWDON
Regulation Number878.5040
Classification Product Code
QPB  
Date Received09/09/2003
Decision Date 11/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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