← Product Code LWE · K952350

# JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) (K952350)

_Promedical , Ltd. · LWE · Jul 17, 1995 · HO · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K952350

## Device Facts

- **Applicant:** Promedical , Ltd.
- **Product Code:** LWE
- **Decision Date:** Jul 17, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class 2
- **Review Panel:** HO

## Regulatory Identification

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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**Source:** [https://fda.innolitics.com/device/K952350](https://fda.innolitics.com/device/K952350)

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