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510(k) K761100

MULTI-CELL ULTRAFILTRATION SYSTEM by Amicon, Inc. — Product Code JQQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1976
Date Received
November 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)
  • K863823 — AMICON DIAFILTER HEMOFILTER (November 6, 1986)