LZE — Isometer Class I
FDA product code LZE covers "Isometer", a Class I medical device regulated under 21 CFR 888.1520. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LZE
- Device Class
- Class I
- Regulation Number
- 888.1520
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950178 | pharma-plast intl | PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SE | July 17, 1995 |