Tube, Heavy Glass Wall Injection

FDA 510(k) K760500 · Unimetrics Corp.

Substantially Equivalent

510(k) numberK760500

Submission

Device name
Tube, Heavy Glass Wall Injection
Applicant
Unimetrics Corp.
Walker, MI, US
Received
August 23, 1976
Decision date
September 3, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXL – Injector, Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1660
Specialty
Cardiovascular

Other 510(k)s with product code DXL

510(k)DeviceApplicantDecision
K760448Syringe, CO2 Driven, Il Automatic InjectDXL · Traditional Instrumentation Laboratory CO08/27/1976SE
K760066Tray, Iced Injectable (26420)DXL · Traditional Instrumentation Laboratory CO07/21/1976SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K7705003 Port LuerEOQ · Traditional 04/05/1977SE

Questions and answers

When was Tube, Heavy Glass Wall Injection cleared by the FDA?

Tube, Heavy Glass Wall Injection (K760500) received a 510(k) decision of Substantially Equivalent on September 3, 1976, 11 days after the submission was received.

What is the product code of K760500?

The FDA product code is DXL – Injector, Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.1660.