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510(k) K892645

AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY by Amicon, Inc. — Product Code KJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1989
Date Received
April 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suspension, Cell Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

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  • K901286 — AMICON HEMOCONCENTRATOR SET (May 18, 1990)
  • K900280 — CENTRIPREP 100 (February 16, 1990)
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  • K893733 — CENTRICON CONCENTRATOR (July 20, 1989)
  • K875121 — AMICON EQUALINE FLUID BALANCE SYSTEM (February 19, 1988)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)
  • K863823 — AMICON DIAFILTER HEMOFILTER (November 6, 1986)
  • K853510 — MINIFILTER HEMOFILTER (September 12, 1985)

Other clearances for product code KJF

  • K893787 — LIFECELL RECOVERY CONTAINER (June 23, 1989)
  • K875221 — TOOTH PRESERVING SYSTEM (April 14, 1988)
  • K780305 — CELL (March 27, 1978)