FDA 483 - POLYREMEDY, INC.

This document is an acknowledgement letter from the FDA to POLYREMEDY, INC. concerning their 510(k) submission K092351 for the POLY FIT + ABSORBING AND HIGH product. The letter confirms receipt of additional information and provides guidance on the premarket review process, including communication protocols and formatting requirements for 510(k) submissions. No inspectional observations or violations were cited in this correspondence.