# FDA 483 - POLYREMEDY, INC. - Unknown Date

Source: https://www.keypedia.com/records/483/polyremedy-inc/43c1713b-9ffb-48be-ac0c-5760152c8d4c

> FDA 483 for POLYREMEDY, INC. on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: POLYREMEDY, INC.
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [510(k) Staff](https://www.keypedia.com/people/510k-staff/3fc46284-e469-44d5-badb-63195f5d9e45)

Company: https://www.keypedia.com/companies/polyremedy-inc/13adc874-8c23-444a-b70e-4c34c5360326

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd