510(k) K925469
K925469 is an FDA 510(k) premarket notification submitted by J.J. Skinner, Inc. for the device "JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT". The FDA issued a decision of Substantially Equivalent on May 3, 1995. The device falls under product code FKG (Tray, Start/Stop (Including Contents), Dialysis), a Class I device regulated under 21 CFR 876.5820. J.J. Skinner, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1995
- Date Received
- October 29, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Start/Stop (Including Contents), Dialysis
- Device Class
- Class I
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type