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FDA 510(k) Application Details - K223388
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K223388
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Medela AG
LΣttichstrasse 4b
Baar 6340 CH
Other 510(k) Applications for this Company
Contact
Judith Bernardo
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
11/07/2022
Decision Date
07/07/2023
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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