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510(k) K790758

HEMOCLEAR U-NEPHROS 1.0 DIALYZER by Medical, Inc. — Product Code FJG

K790758 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "HEMOCLEAR U-NEPHROS 1.0 DIALYZER". The FDA issued a decision of Substantially Equivalent on May 8, 1979. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Medical, Inc. has 21 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1979
Date Received
Apr 17, 1979
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
510(k)

Other clearances by Medical, Inc.

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

Other clearances for product code FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (Sep 7, 1994)
  • K933680 — GAMBRO LUNDIA PRO 200 DIALYZER (Aug 26, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (Sep 21, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (Mar 6, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (Aug 2, 1990)
  • K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT (Aug 1, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (Sep 29, 1986)
  • K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER (Jan 8, 1986)
  • K820694 — COBE PPD 1.3L, #18-520-009 (Mar 31, 1982)
  • K812336 — COBE PPD 1.9 (Aug 31, 1981)

FDA data resources

Source: FDA 510(k) database entry for K790758. Report a data issue: hello@regdatalab.com.