(27 days)
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I apologize, but the document you provided is an FDA notification letter regarding an administrative change to a device's product code. It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. Therefore, I cannot extract the requested information.
To answer your request, I would need a document that describes the device's performance characteristics and the studies conducted to demonstrate its effectiveness and safety.
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July 28, 2023
Z-Medica Corporation c/o Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K080247
Trade/Device Name: QuikClot® Nosebleed™ Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA
Dear Mary McNamara-Cullinane:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 27, 2008 and correction letter dated January 4, 2010. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code LYA.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.