G.E. Sterile Angiographic Tray

FDA 510(k) K960139 · GE Medical Systems

Unknown

510(k) numberK960139

Submission

Device name
G.E. Sterile Angiographic Tray
Applicant
GE Medical Systems
Palm Harbor, FL, US
Received
January 16, 1996
Decision date
April 19, 1996
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DWS – Instruments, Surgical, Cardiovascular
Device class
Class I (low risk)
Regulation
21 CFR 870.4500
Specialty
Cardiovascular

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K955689RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional Contour Fabricators of Florida, Inc.05/15/1996SE
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Questions and answers

When was G.E. Sterile Angiographic Tray cleared by the FDA?

G.E. Sterile Angiographic Tray (K960139) received a 510(k) decision of Unknown on April 19, 1996, 94 days after the submission was received.

What is the product code of K960139?

The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.