510(k) K831423

THERAPEUTIC EXCHANGE SYSTEM by Extracorporeal Medical Specialities, Inc. — Product Code LQQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
May 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Columns, Immunoadsorption In Extracorporeal Systems
Device Class
Class III
Regulation Number
Review Panel
GU
Submission Type