← Product Code [KFX](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX) · K932184

# STERILE LEMAITRE GLOW 'N TELL TAPE (K932184)

_Vascutech, Inc. · KFX · Jul 22, 1993 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX/K932184

## Device Facts

- **Applicant:** Vascutech, Inc.
- **Product Code:** [KFX](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX.md)
- **Decision Date:** Jul 22, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3500
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX/K932184](https://fda.innolitics.com/submissions/RA/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KFX/K932184)

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