Cleared Traditional

K780570 - TUBULAR DRESSING RETAINER
(FDA 510(k) Clearance)

K780570 · Alba-Waldensian, Inc. · General Hospital

Apr 1978

Decision

Days

Class 1

Risk

K780570 is an FDA 510(k) clearance for the TUBULAR DRESSING RETAINER. This device is classified as a Bandage, Elastic (Class I — General Controls, product code FQM).

Submitted by Alba-Waldensian, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1978, 9 days after receiving the submission on April 10, 1978.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K780570 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1978
Decision Date	April 19, 1978
Days to Decision	9 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—