Product code LZE— Orthopedic
PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
- Classification name
- Isometer
- Device class
- Class 1
- Regulation
- 21 CFR 888.1520
- Advisory panel
- Orthopedic
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LZE
FDA has cleared device under product code LZE, all in 1995, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code LZE
Recent clearances under product code LZE
Data sourced from openFDA. This site is unofficial and independent of the FDA.