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510(k) K760085

BASIN, STERILE (#3200) by Concord Laboratories, Inc. — Product Code FNY

K760085 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "BASIN, STERILE (#3200)". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code FNY (Basin, Emesis), a Class I device regulated under 21 CFR 880.6730. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1976
Date Received
June 21, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Basin, Emesis
Device Class
Class I
Regulation Number
880.6730
Review Panel
HO
Submission Type

Other clearances by Concord Laboratories, Inc.

  • K883840 — DRI-VENT ARTERIAL BLOOD SAMPLING KIT (May 16, 1989)
  • K871825 — MECONIUM SUCTION CATHETER (June 29, 1987)
  • K864535 — TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 (January 6, 1987)
  • K862039 — CONCORD CARE TRAY (July 3, 1986)
  • K854601 — SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH (January 10, 1986)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K851134 — REGIONAL ANESTHESIA TRAYS (July 15, 1985)
  • K842095 — EPIDURAL TRAYS (July 3, 1984)
  • K841486 — ARTERIAL BLOOD SAMPLING KITS (May 23, 1984)
  • K840987 — VAPORIZED HEPARIN (April 5, 1984)

Other clearances for product code FNY

  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K802538 — BASIN PACK (October 31, 1980)
  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K792625 — STERILIZATION PROCESS/PLACENTA BASIN (January 16, 1980)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)

FDA data resources