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FDA 510(k) Application Details - K180840
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K180840
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Genadyne Biotechnologies, Inc.
16 Midland Ave
Hicksville, NY 11801 US
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Contact
Andrew Goh
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
03/30/2018
Decision Date
11/30/2018
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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