ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
Device Facts
| Record ID | K822240 |
|---|---|
| Device Name | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. |
| Applicant | American Mcgaw |
| Product Code | KFX · Physical Medicine |
| Decision Date | Dec 30, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3500 |
| Device Class | Class 2 |
Regulatory Classification
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.
