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510(k) Data Aggregation
K Number
K032301Device Name
NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
Manufacturer
NEOGEN TECHNOLOGIES, INC
Date Cleared
2003-08-21
(27 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
NEOGEN TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner.
Device Description
NeoGen One. Closed Wound Drain System Part Number: NG9900
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