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510(k) K920697

DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP by National Medical Care, Medical Products Div., Inc. — Product Code FJH

K920697 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP". The FDA issued a decision of Substantially Equivalent on September 21, 1992. The device falls under product code FJH (Dialyzer, Disposable), a Class II device regulated under 21 CFR 876.5830. 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, Disposable
Device Class
Class II
Regulation Number
876.5830
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)
  • K920029 — DEXTROLYTE II CAPD TRNSFER SET (September 21, 1992)
  • K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (September 21, 1992)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K920797 — HEMODIALYSIS BLOOD TUBING SET (September 21, 1992)
  • K915628 — DEXTROLYTE II PERITONEAL DIALYSIS PUMP (March 16, 1992)

Other clearances for product code FJH

  • K861646 — BIO-CARB D16000, D16001, AND D17000 (August 7, 1986)
  • K852764 — IDECAP DIALYZER (September 20, 1985)
  • K822395 — CF 1211 CAPILLARY FLOW DIALYZER CODE (August 12, 1982)

FDA data resources