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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 K170449
Device Name Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
Applicant
Millennium Medical Technologies, Inc.
6352 Corte Del Abeto
Suite A
Carlsbad,  CA  92011
Applicant Contact Jim Barley
Correspondent
Millennium Medical Technologies, Inc.
6352 Corte Del Abeto
Suite A
Carlsbad,  CA  92011
Correspondent Contact Jim Barley
Regulation Number878.5040
Classification Product Code
MUU  
Date Received02/15/2017
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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