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510(k) K831082

CONNECTING TUBING by The Kendall Company Div. of Tyco Healthcare Group — Product Code BYX

K831082 is an FDA 510(k) premarket notification submitted by The Kendall Company Div. of Tyco Healthcare Group for the device "CONNECTING TUBING". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. The Kendall Company Div. of Tyco Healthcare Group has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type

Other clearances by The Kendall Company Div. of Tyco Healthcare Group

  • K024010 — DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER (June 11, 2003)
  • K831081 — EZEE FILTER/SEPARATOR (May 16, 1983)
  • K831079 — LIQUIPETTE (April 28, 1983)

Other clearances for product code BYX

  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K955656 — NORTH STATE PLASTICS AEROSOL TEE (March 6, 1996)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K935835 — BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES (January 12, 1994)
  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K913422 — OXYGEN TUBING, 81503 (January 30, 1992)
  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)

FDA data resources