510(k) K910173
K910173 is an FDA 510(k) premarket notification submitted by Medionics International , Ltd. for the device "SELECTRA AND TUBING SETS". The FDA issued a decision of Substantially Equivalent on January 13, 1992. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Medionics International , Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1992
- Date Received
- January 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Peritoneal, Automatic Delivery
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type