Cleared Traditional

K833732 - NON WETTING UNDERCAST PADDING (FDA 510(k) Clearance)

K833732 · American Medical Disposable, Inc. · Physical Medicine device

Dec 1983

Decision

48d

Days

Class 1

Risk

K833732 is an FDA 510(k) clearance for the NON WETTING UNDERCAST PADDING. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983, 48 days after receiving the submission on October 25, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3025.

Submission Details

510(k) Number	K833732 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 25, 1983
Decision Date	December 12, 1983
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—