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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K211521
Device Name 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
Applicant
3M Healthcare Business Group
6203 Farinon Dr.
San Antonio,  TX  78249
Applicant Contact Margaret Marsh
Correspondent
3M Healthcare Business Group
6203 Farinon Dr.
San Antonio,  TX  78249
Correspondent Contact Margaret Marsh
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/17/2021
Decision Date 12/20/2021
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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