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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. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21 CFR 801 Subpart C CONTINUE ON A SEPARATE PAGE IF NEEDED. BZ Elite Medical Supply of New York LLC John McGrady Operations Manager 1900 Ridge Rd. Suite 125 West Seneca New York 14224 Re K171387 Trade/Device Name...
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Elite Medical Supply provides a range of medical equipment and supplies.
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Healthcare providers and medical facilities are required to file Elite Medical Supply.
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To fill out Elite Medical Supply, providers must include information about the medical equipment and supplies being purchased.
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The purpose of Elite Medical Supply is to track the purchase and usage of medical equipment and supplies.
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Information such as the type of equipment, quantity purchased, and patient usage must be reported on Elite Medical Supply.
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