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FDA 510(k) Application Details - K181929
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K181929
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Baymax Research, Inc.
315 W36th St
New York, NY 10018 US
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Contact
Richard Chen
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
OMP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2018
Decision Date
03/27/2019
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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