Cleared Traditional

K912824 - DEVON SPONGE COUNTER BAGS
(FDA 510(k) Clearance)

K912824 · Devon Industries, Inc. · General & Plastic Surgery device

Aug 1991

Decision

61d

Days

Class 1

Risk

K912824 is an FDA 510(k) clearance for the DEVON SPONGE COUNTER BAGS. This device is classified as a Counter, Sponge, Surgical (Class I - General Controls, product code LWH).

Submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on August 26, 1991, 61 days after receiving the submission on June 26, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.2740.

Submission Details

510(k) Number	K912824 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 26, 1991
Decision Date	August 26, 1991
Days to Decision	61 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement