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Mammography Facilities - accessdata.fda.gov
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Webfacility phone number city ... Piedmont Outpatient Cente (770) 2543252 Newnan, GA 30265 Piedmont Newnan Faye Hend (770) 4004305 Newnan, GA 30265 Southeastern Regional Med ... U.S. Food and Drug Administration. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA ... WebFDA Determined Cause 2: Other: Action: Consignees were notified by phone and fax on 07/01/2004. Quantity in Commerce: 405 units: Distribution: Nationwide, including VA … FDA does not intend to propose regulatory changes relating to drug requirements for convenience kits. For convenience kits that contain components subject to regulation as drugs, the assembler/manufacturer should contact Kevin Budich, Center for Drug Evaluation and Research, Division of New Drugs and … See more Under the current regulations, first time marketers of devices must submit a premarket notification and obtain clearance for a device before it can be lawfully introduced … See more Based on this experience, FDA believes that under certain circumstances premarket clearance for convenience kits may not be … See more The attached list of convenience kits was developed based on FDA's database and is organized by medical speciality. For purposes of this document, the terms "kit," "set," and "tray" are considered synonymous. This … See more frobose specials