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K Number
K994339
Device Name
HYCURE ORAL / HYCURE ORAL SMART GEL
Manufacturer
THE HYMED GROUP CORP.
Date Cleared
2000-03-22

(90 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
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.

N/A