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510(k) K010366

DISPOSABLE STORAGE CAP by Molded Products, Inc. — Product Code FJI

K010366 is an FDA 510(k) premarket notification submitted by Molded Products, Inc. for the device "DISPOSABLE STORAGE CAP". The FDA issued a decision of Substantially Equivalent on November 28, 2001. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Molded Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2001
Date Received
February 7, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Molded Products, Inc.

  • K022068 — TUBING, DIALYSATE (AND CONNECTOR) (September 23, 2002)
  • K010712 — DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (September 27, 2001)
  • K003712 — MODIFICATION TO MALE TO MALE LUER ADAPTER (May 16, 2001)
  • K925978 — MPC-80 TRANSDUCER (January 14, 1994)
  • K925930 — MPC-150 MALE TO MALE LUER ADAPTER (August 16, 1993)
  • K925927 — MPC-1000 INJECTION CAP/PLUG (August 16, 1993)

Other clearances for product code FJI

  • K190459 — Hemoflow F3 and F4 Dialyzers (August 23, 2019)
  • K122952 — NIPRO PUREFLUX-L HEMODIALYZER (December 4, 2013)
  • K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS (May 27, 2005)
  • K011148 — ULTRACONCENTRATOR SYSTEM (June 13, 2001)
  • K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (December 4, 2000)
  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)
  • K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (April 19, 1999)

FDA data resources