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K Number
K982648
Device Name
JOAN II
Manufacturer
CELANESE ACETATE CO.
Date Cleared
1998-09-30

(63 days)

Product Code
EFQ,EFO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

JoAn II ™ is designed for external application for use in absorbing fluids.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device named "JoAn II™," which is described as being "designed for external application for use in absorbing fluids." This document does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, expert qualifications, or sample sizes for training or testing.

Therefore, I cannot provide the requested information. The letter only confirms that the device has been found substantially equivalent to a pre-amendment device and can be legally marketed.

N/A