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510(k) K820694

COBE PPD 1.3L, #18-520-009 by Cobe Laboratories, Inc. — Product Code FJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1982
Date Received
March 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (August 2, 1990)
  • K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT (August 1, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (September 29, 1986)
  • K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER (January 8, 1986)
  • K812336 — COBE PPD 1.9 (August 31, 1981)
  • K811440 — EXP 600 PARALLEL PLATE DIALYZER (June 12, 1981)