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1RYHPEHU
Cogent ix Medical, Inc.
Christa Blaisdell
Regulatory Affairs Specialist
40 Ram land Road South
Orange burg, NY 10962
Re: K181292
Trade/Device Name: Prizefight UNITY 9000 Video Processor,
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What is form fda 3514113pdf?
Form FDA 3514 is a form used for drug establishment registration and drug listing with the Food and Drug Administration (FDA).
Who is required to file form fda 3514113pdf?
All drug manufacturers, repackers, relabelers, and distributors are required to file Form FDA 3514.
How to fill out form fda 3514113pdf?
Form FDA 3514 can be filled out electronically on the FDA's website or manually and submitted by mail.
What is the purpose of form fda 3514113pdf?
The purpose of Form FDA 3514 is to register drug establishments and list all drugs manufactured, repacked, relabeled, or distributed by the establishment.
What information must be reported on form fda 3514113pdf?
Information such as establishment name, address, drug listing information, and unique facility identifier (UFI) must be reported on Form FDA 3514.
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