Home / 510(k) Clearances / K852049

510(k) K852049

MEDICAL TOILET SEAT by Pedro Aleman — Product Code ILS

K852049 is an FDA 510(k) premarket notification submitted by Pedro Aleman for the device "MEDICAL TOILET SEAT". The FDA issued a decision of Substantially Equivalent on June 24, 1985. The device falls under product code ILS (Adaptor, Hygiene), a Class I device regulated under 21 CFR 890.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1985
Date Received
May 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Hygiene
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances for product code ILS

  • K842651 — COMMODE CHAIR 98200 (August 7, 1984)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830425 — TOILET SEAT RAISED (May 9, 1983)
  • K830852 — SHOWER STOOL W/HANDLES (April 5, 1983)
  • K823641 — BATHING CHAIR FOR CHILD (January 21, 1983)
  • K823626 — DISPOSABLE TOOTH BRUSH (December 30, 1982)
  • K823606 — PLASTIC BREAK RESISTANT MIRROR (December 28, 1982)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)

FDA data resources