Cleared Traditional

K821009 - BATHTUB GRAB BAR
(FDA 510(k) Clearance)

K821009 · Guardian Products Co., Inc. · Physical Medicine device

Apr 1982

Decision

Days

Class 1

Risk

K821009 is an FDA 510(k) clearance for the BATHTUB GRAB BAR. This device is classified as a Adaptor, Hygiene (Class I - General Controls, product code ILS).

Submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982, 9 days after receiving the submission on April 12, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number	K821009 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 12, 1982
Decision Date	April 21, 1982
Days to Decision	9 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—