510(k) K961026
K961026 is an FDA 510(k) premarket notification submitted by Dayspring Medical, Inc. for the device "BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL". The FDA issued a decision of Substantially Equivalent on June 10, 1996. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Dayspring Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1996
- Date Received
- March 14, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, Capillary, Hollow Fiber
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type