FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a Non-Woven Sponge, indicating that the device is substantially equivalent to legally marketed predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on the regulatory clearance process and does not delve into the detailed technical or clinical studies that might be associated with evaluating the device's performance against specific criteria.

Ask a Question

Ask a specific question about this device

K Number

K960388

Device Name

DYNAREX NON-WOVEN SPONGE

Manufacturer

DYNAREX CORP.

Date Cleared

1996-04-01

(66 days)

Product Code