510(k) K950178
K950178 is an FDA 510(k) premarket notification submitted by Pharma-Plast Intl. A/S for the device "PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET". The FDA issued a decision of Substantially Equivalent on July 17, 1995. The device falls under product code LZE (Isometer), a Class I device regulated under 21 CFR 888.1520. Pharma-Plast Intl. A/S has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1995
- Date Received
- January 17, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Isometer
- Device Class
- Class I
- Regulation Number
- 888.1520
- Review Panel
- OR
- Submission Type