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510(k) K821009

BATHTUB GRAB BAR by Guardian Products Co., Inc. — Product Code ILS

K821009 is an FDA 510(k) premarket notification submitted by Guardian Products Co., Inc. for the device "BATHTUB GRAB BAR". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code ILS (Adaptor, Hygiene), a Class I device regulated under 21 CFR 890.5050. Guardian Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1982
Date Received
April 12, 1982
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 by Guardian Products Co., Inc.

  • K915108 — FOLDING WHEELCHAIR (January 13, 1992)
  • K842650 — WALL GRAB BARS 98130-98136 (August 10, 1984)
  • K842649 — BATH TUB TRANSFER CHAIR (August 10, 1984)
  • K842651 — COMMODE CHAIR 98200 (August 7, 1984)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)
  • K790299 — FOREARM-CANE (February 21, 1979)
  • K772049 — WALKING AID (November 11, 1977)

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)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)

FDA data resources