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510(k) Data Aggregation
K Number
K994339Device Name
HYCURE ORAL / HYCURE ORAL SMART GELManufacturer
Date Cleared
2000-03-22
(90 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
HYCURE ORAL / HYCURE ORAL SMART GEL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
For the management of oral wounds and sores, including:
- Denture sores
- Oral ulcers (non-infected or viral)
- Oral dicorp (surgical wounds)
- Suture sites
- Burns
- Extraction sites
- Surgical wounds
- Traumatic wounds
Device Description
Not Found
AI/ML Overview
The provided text is a letter from the FDA regarding a medical device, Hycure Oral/Hycure Oral Smart Gel, and discusses its regulatory classification, labeling limitations, and substantial equivalence.
It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement for a medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
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