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510(k) K830835

STERILE 5 IN 1 CONNECTORS by Abco Dealers, Inc. — Product Code GAZ

K830835 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "STERILE 5 IN 1 CONNECTORS". The FDA issued a decision of Substantially Equivalent on April 6, 1983. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1983
Date Received
March 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

Other clearances for product code GAZ

  • K952605 — SUCTION/IRRIGATOR TUBING KIT (September 15, 1995)
  • K945978 — TUBING, NONINVASIVE (January 11, 1995)
  • K930512 — SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (July 23, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (March 8, 1991)
  • K910171 — MAXI-FLOW SUCTION SET W/Y CONNECTOR (February 1, 1991)
  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K882315 — VIR-A-VAC EMPTY (September 26, 1988)
  • K883473 — SURGICAL CONNECTING TUBES (August 25, 1988)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)

FDA data resources