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510(k) K801451

ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM by Medical, Inc. — Product Code FJG

K801451 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
June 23, 1980
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

Other clearances by Medical, Inc.

  • K082311 — EXSUDEX WOUND DRAINAGE PUMP (October 8, 2008)
  • K926454 — ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON (June 22, 1993)
  • K894839 — OS-1 OCCLUSION SYSTEM - 1 (October 24, 1989)
  • K872001 — MODEL TPC-1A OXYGEN ANALYZER (June 15, 1987)
  • K863806 — MODEL A-1 OXYGEN ANALYZER (October 15, 1986)
  • K862591 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 (September 4, 1986)
  • K862609 — INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 (September 4, 1986)
  • K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (June 2, 1986)
  • K851370 — INTERFACE TRANSFUSION BLOOD FILTER #35 (June 27, 1985)
  • K823261 — INTERFACE TRANSFUSION BLOOD FILTER #30 (January 7, 1983)

Other clearances for product code FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (September 7, 1994)
  • K933680 — GAMBRO LUNDIA PRO 200 DIALYZER (August 26, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • 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)
  • K820694 — COBE PPD 1.3L, #18-520-009 (March 31, 1982)
  • K812336 — COBE PPD 1.9 (August 31, 1981)

FDA data resources