Home / 510(k) Clearances / K802511

510(k) K802511

GARELICK COMMODE by Garelick Mfg. Co. — Product Code ILS

K802511 is an FDA 510(k) premarket notification submitted by Garelick Mfg. Co. for the device "GARELICK COMMODE". The FDA issued a decision of Substantially Equivalent on November 12, 1980. 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
November 12, 1980
Date Received
October 15, 1980
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

  • K852049 — MEDICAL TOILET SEAT (June 24, 1985)
  • 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)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)

FDA data resources