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510(k) K860877

FLEXTUBE, CONNECTING TUBING by Dhd Medical Products Div. Diemolding Corp. — Product Code BYX

K860877 is an FDA 510(k) premarket notification submitted by Dhd Medical Products Div. Diemolding Corp. for the device "FLEXTUBE, CONNECTING TUBING". The FDA issued a decision of Substantially Equivalent on March 20, 1986. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Dhd Medical Products Div. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1986
Date Received
February 25, 1986
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 Dhd Medical Products Div. Diemolding Corp.

  • K883988 — NON-REBREATHING TEE PIECE (NRTP) (October 7, 1988)
  • K881935 — MICROCIRRUS MEDICAL NEBULIZER (June 22, 1988)
  • K881178 — CUFFCHECK (April 14, 1988)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)
  • K874047 — ASTHMAKIT (February 29, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (October 30, 1987)
  • K860879 — DISPOSABLE VENTILATOR CIRCUITS (March 20, 1986)
  • K860875 — CIRRUS DRUG NEBULIZER MK III (March 20, 1986)
  • K860878 — BRITISH BREATHING CIRCUIT SYSTEM (March 20, 1986)
  • K860882 — DISPOSABLE CATHETER (March 20, 1986)

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)
  • K931043 — MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
  • K931033 — MF CHEMETRON 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