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FDA 510(k) Application Details - K202217
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K202217
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Cardinal Health
3651 Birchwood Drive
Waukegan, IL 60085 US
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Contact
Christine Kuntz-Nassif
Other 510(k) Applications for this Contact
Regulation Number
878.4780
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Classification Product Code
OMP
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More FDA Info for this Product Code
Date Received
08/06/2020
Decision Date
06/04/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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