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510(k) K760490

BEDPAN, GENERAL MEDICAL MEDI-PAK by Landmark Plastics — Product Code FOB

K760490 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "BEDPAN, GENERAL MEDICAL MEDI-PAK". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code FOB (Bedpan), 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
Bedpan
Device Class
Class I
Regulation Number
880.6730
Review Panel
HO
Submission Type

Other clearances by Landmark Plastics

  • K760497 — TRAY, SERVICE (November 12, 1976)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)
  • K760548 — CARAFE AND LINER (November 12, 1976)
  • K760493 — DISH, SOAP (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)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760491 — TUMBLER, GENERAL MEDICAL MEDI-PAK (September 15, 1976)

Other clearances for product code FOB

  • K791346 — DISPOSABLE BEDPAN (August 3, 1979)
  • K780370 — STAND UP TOILET (April 10, 1978)
  • K760393 — BED PAN, STACKABLE (AUTOCLAVABLE) (August 23, 1976)
  • K760307 — BEDPAN, SINGLE PATIENT USE, TECNOL (August 11, 1976)

FDA data resources