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FDA 510(k) Application Details - K190742
Device Classification Name
Chamber, Oxygen, Topical, Extremity
More FDA Info for this Device
510(K) Number
K190742
Device Name
Chamber, Oxygen, Topical, Extremity
Applicant
Neogenix, LLC dba Ogenix
3401 Enterprise Pkwy, Suite 340
Beachwood, OH 44122 US
Other 510(k) Applications for this Company
Contact
Srinivasan Sarangapani
Other 510(k) Applications for this Contact
Regulation Number
878.5650
More FDA Info for this Regulation Number
Classification Product Code
KPJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2019
Decision Date
12/13/2019
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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