510(k) K873279
K873279 is an FDA 510(k) premarket notification submitted by Cd Medical, Inc. for the device "8810 PUMP-PUMP SINGLE NEEDLE DEVICE". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump), a Class II device regulated under 21 CFR 876.5820. Cd Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1987
- Date Received
- August 17, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Dialysis, Single Needle With Uni-Directional Pump
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type