(362 days)
POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.
BACTERISTATIC NASAL DRESSING
I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Bacteristatic Nasal Dressing." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any information related to multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
This document is purely a regulatory clearance notice and does not delve into the specific technical or clinical study data that would inform such a description.
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(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 § 874.9.