510(k) K792207
K792207 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "PERIDIAL PERITONEAL DIALYSIS TRAY". The FDA issued a decision of Substantially Equivalent on December 10, 1979. The device falls under product code FKG (Tray, Start/Stop (Including Contents), Dialysis), a Class I device regulated under 21 CFR 876.5820. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1979
- Date Received
- November 2, 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