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510(k) K813074

CONNECTORS & ADAPTERS by Seven Harvest Intl. Import & Export — Product Code BYX

K813074 is an FDA 510(k) premarket notification submitted by Seven Harvest Intl. Import & Export for the device "CONNECTORS & ADAPTERS". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code BYX (Tubing, Pressure And Accessories), a Class I device regulated under 21 CFR 868.5860. Seven Harvest Intl. Import & Export has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
November 2, 1981
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 Seven Harvest Intl. Import & Export

  • K940793 — DOUBLE TRACH SWIVEL CONNECTOR (July 1, 1994)
  • K823506 — NASAL CANNULA (December 9, 1982)
  • K823141 — OXYGEN MASKS (November 29, 1982)
  • K823142 — OXYGEN TUBINGS (November 29, 1982)
  • K823143 — BUBBLE HUMIDIFIERS (November 29, 1982)
  • K820709 — AIRWAYS (June 25, 1982)

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