510(k) K790382
K790382 is an FDA 510(k) premarket notification submitted by Estracorporeal, Inc. for the device "COIL DIALYSIS, MODELS DM-360 AND DM-360-". The FDA issued a decision of Substantially Equivalent on May 2, 1979. The device falls under product code FKD (Canister, Coil), a Class II device regulated under 21 CFR 876.5820. Estracorporeal, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1979
- Date Received
- February 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Canister, Coil
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type