Cleared Traditional

G.E. STERILE AMNIOCENTESIS TRAY

K960203 · GE Medical Systems · Obstetrics & Gynecology

Mar 1996

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K960203 is an FDA 510(k) clearance for the G.E. STERILE AMNIOCENTESIS TRAY, a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I — General Controls, product code HIO), submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on March 14, 1996, 58 days after receiving the submission on January 16, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1550.

Submission Details

510(k) Number	K960203 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1996
Decision Date	March 14, 1996
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement