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510(k) K772163

DIALYSIS MACHINES DM-346 & 346-1 by Extracorporeal Medical Specialities, Inc. — Product Code FIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1977
Date Received
November 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Recirculating, Single Pass
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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