Home / 510(k) Clearances / K790382

510(k) K790382

COIL DIALYSIS, MODELS DM-360 AND DM-360- by Estracorporeal, Inc. — Product Code FKD

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

Other clearances by Estracorporeal, Inc.

  • K915130 — MAT MEMBRANE AUTOTRANSFUSION SYSTEM (February 22, 1993)