Cleared Traditional

VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE

K922960 · Cameo, Inc. · Obstetrics & Gynecology

Nov 1992

Decision

140d

Days

Class 1

Risk

About This 510(k) Submission

K922960 is an FDA 510(k) clearance for the VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE, a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I — General Controls, product code HIO), submitted by Cameo, Inc. (Toledo, US). The FDA issued a Cleared decision on November 5, 1992, 140 days after receiving the submission on June 18, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1550.

Submission Details

510(k) Number	K922960 FDA.gov
FDA Decision	Cleared SEKD
Date Received	June 18, 1992
Decision Date	November 05, 1992
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement