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510(k) K760496

CUP, DISPOSABLE SPECIMEN by Landmark Plastics — Product Code FMH

K760496 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "CUP, DISPOSABLE SPECIMEN". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. 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
Container, Specimen, Sterile
Device Class
Class I
Regulation Number
864.3250
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)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760548 — CARAFE AND LINER (November 12, 1976)
  • K760491 — TUMBLER, GENERAL MEDICAL MEDI-PAK (September 15, 1976)

Other clearances for product code FMH

  • K900983 — TRI-TECH URINE SPECIMEN KIT (September 17, 1990)
  • K823763 — VARIOUS-SPECIMEN COLLECTORS (January 19, 1983)
  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802340 — SPECIMEN SET (October 10, 1980)
  • K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016 (September 9, 1980)
  • K800947 — MIDSTREAM COLLECTION KIT (May 30, 1980)
  • K800309 — SPECIMEN COLLECTION PAN (February 26, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)

FDA data resources