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510(k) K022068

TUBING, DIALYSATE (AND CONNECTOR) by Molded Products, Inc. — Product Code FID

K022068 is an FDA 510(k) premarket notification submitted by Molded Products, Inc. for the device "TUBING, DIALYSATE (AND CONNECTOR)". The FDA issued a decision of Substantially Equivalent on September 23, 2002. The device falls under product code FID (Tubing, Dialysate), 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
September 23, 2002
Date Received
June 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Dialysate
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Molded Products, Inc.

  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • 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 FID

  • K010712 — DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (September 27, 2001)
  • K770299 — TYGON M-60/TYGON M-70 (March 16, 1977)

FDA data resources