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510(k) K010712

DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES by Molded Products, Inc. — Product Code FID

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2001
Date Received
March 9, 2001
Clearance Type
Abbreviated
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.

  • K022068 — TUBING, DIALYSATE (AND CONNECTOR) (September 23, 2002)
  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K003712 — MODIFICATION TO MALE TO MALE LUER ADAPTER (May 16, 2001)
  • K925978 — MPC-80 TRANSDUCER (January 14, 1994)
  • K925927 — MPC-1000 INJECTION CAP/PLUG (August 16, 1993)
  • K925930 — MPC-150 MALE TO MALE LUER ADAPTER (August 16, 1993)

Other clearances for product code FID

  • K022068 — TUBING, DIALYSATE (AND CONNECTOR) (September 23, 2002)
  • K770299 — TYGON M-60/TYGON M-70 (March 16, 1977)