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510(k) K760494

BASIN, ROUND WASH by Landmark Plastics — Product Code FNY

K760494 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "BASIN, ROUND WASH". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code FNY (Basin, Emesis), a Class I device regulated under 21 CFR 880.6730. Landmark Plastics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1976
Date Received
August 23, 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 Landmark Plastics

  • K760490 — BEDPAN, GENERAL MEDICAL MEDI-PAK (November 12, 1976)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)
  • K760493 — DISH, SOAP (November 12, 1976)
  • K760497 — TRAY, SERVICE (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760552 — THERMOMETER STAND AND DUST COVER (November 12, 1976)
  • K760496 — CUP, DISPOSABLE SPECIMEN (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760548 — CARAFE AND LINER (November 12, 1976)
  • K760491 — TUMBLER, GENERAL MEDICAL MEDI-PAK (September 15, 1976)

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)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760085 — BASIN, STERILE (#3200) (July 20, 1976)

FDA data resources