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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 K170629
Device Name VITRUVIAN INFILTRATION PUMP
Applicant
Black & Black Surgical, Inc.
5238 Royal Woods Pkwy., Suite 170
Tucker,  GA  30084
Applicant Contact CYNTHIA REES
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.5040
Classification Product Code
QPB  
Date Received03/02/2017
Decision Date 06/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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