Cleared Traditional

VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE

K922962 · Cameo, Inc. · General Hospital

Mar 1993

Decision

278d

Days

Class 2

Risk

About This 510(k) Submission

K922962 is an FDA 510(k) clearance for the VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Cameo, Inc. (Toledo, US). The FDA issued a Cleared decision on March 23, 1993, 278 days after receiving the submission on June 18, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K922962 FDA.gov
FDA Decision	Cleared SEKD
Date Received	June 18, 1992
Decision Date	March 23, 1993
Days to Decision	278 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement