510(k) K790353
K790353 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "ACUTE RENAL DIALYSIS TRAY". The FDA issued a decision of Substantially Equivalent on April 20, 1979. The device falls under product code FKG (Tray, Start/Stop (Including Contents), Dialysis), a Class I device regulated under 21 CFR 876.5820. Argon Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1979
- Date Received
- February 22, 1979
- 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