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510(k) K920693

DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 by National Medical Care, Medical Products Div., Inc. — Product Code FJG

K920693 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9". The FDA issued a decision of Substantially Equivalent on September 21, 1992. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1992
Date Received
February 14, 1992
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 National Medical Care, Medical Products Div., Inc.

  • K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET (November 1, 1996)
  • K941757 — FORMALIN REUSE CART (January 22, 1996)
  • K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (December 22, 1995)
  • K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (August 31, 1994)
  • K914790 — HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R (March 5, 1993)
  • K920797 — HEMODIALYSIS BLOOD TUBING SET (September 21, 1992)
  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (September 21, 1992)
  • K920029 — DEXTROLYTE II CAPD TRNSFER SET (September 21, 1992)
  • K915628 — DEXTROLYTE II PERITONEAL DIALYSIS PUMP (March 16, 1992)

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)
  • 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)
  • K811439 — EXP 200 PARALLEL PLATE DIALYZER (June 12, 1981)

FDA data resources