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MlD 20993-0002 July 17 2014 Ms. Sheila K. Wallin Vice President of Clinical U.S. Regulatory Affairs 4 Fairfield Boulevard Wallingford Connecticut 06492 Re K140757 Trade/Device Name D2 Hemostatic Dressing Regulatory Class Unclassified Dated April 29 2014 Received May 1. Fda.gov/Medica Devices/ResourcesforYou/Industrv/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 2ICFR Part 807. 510 k Summary for Z-Medica LLC 112 Hemostatic Dressing JUL...
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Z-Medica LLC is a company that specializes in developing hemostatic medical products.
The owners or authorized representatives of Z-Medica LLC are required to file the necessary paperwork.
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The purpose of filing for Z-Medica LLC is to ensure compliance with regulatory requirements and maintain accurate records of the company's activities.
Information such as financial statements, ownership details, business activities, and other relevant data must be reported for Z-Medica LLC.
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