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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 January 11 2017 Caldera Medical Inc. Vicki Gail Director Quality and Regulatory 5171 Clareton Drive Agoura Hills CA 91301 Re K162201 Trade/Device...
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Caldera Medical Inc is a medical device company that specializes in the development and manufacturing of products for the treatment of stress urinary incontinence and pelvic organ prolapse.
Caldera Medical Inc is required to file financial and corporate documents with regulatory authorities, shareholders, and other relevant parties.
To fill out Caldera Medical Inc, one must provide accurate information about the company's financial status, ownership structure, and operational activities.
The purpose of Caldera Medical Inc is to improve the quality of life for patients suffering from stress urinary incontinence and pelvic organ prolapse by providing innovative medical devices.
Information such as financial statements, ownership details, product information, regulatory compliance status, and any other relevant data must be reported on Caldera Medical Inc.
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