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510(k) K761358

COIL DIALYZER MODEL ALT 140 by Bentley Laboratories, Inc. — Product Code FHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1977
Date Received
December 29, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Single Coil
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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Other clearances for product code FHS

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  • K800723 — MICRO-COIL 100 COIL DIALYZER (May 14, 1980)
  • K800174 — GAMBRO LUNDIA COIL DIALYZER (February 13, 1980)
  • K790223 — DIALYZER, CD-800 COIL (March 26, 1979)
  • K781102 — DIALYZER, DISP., COIL, LUNDIA (October 17, 1978)
  • K771349 — MODIFICATION TO KIDNEY DIALYZER (August 2, 1977)
  • K770735 — DIALYZER, COIL, CD, LSA, 5M1765 (May 10, 1977)
  • K760702 — ERI-FLO 900 DIALYZER (November 19, 1976)