Model FEL5100 Floor Light

FDA 510(k) K895950 · F.W. Lang Co.

Substantially Equivalent

510(k) numberK895950

Submission

Device name
Model FEL5100 Floor Light
Applicant
F.W. Lang Co.
Clifton Heights, PA, US
Received
October 10, 1989
Decision date
October 31, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FSS – Light, Surgical, Floor Standing
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code FSS

510(k)DeviceApplicantDecision
K091246Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)FSS · Abbreviated Trumpf Medizin Systeme GmbH + Co. KG09/28/2009SE
K003489Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…FSS · Traditional Medical Illumination International, Inc.02/02/2001SE
K984124Aesculap Xenon Light SourceFSS · Traditional Aesculap, Inc.02/01/1999SE
K981962Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional Cuda Products Co.08/18/1998SE
K981821Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional Angiolaz, Inc.07/29/1998SE
K981469CERMAX300 LightsourceFSS · Traditional Cuda Products Co.07/09/1998SE
K980044Xenon 300MXFSS · Traditional Perkinelmer Optoelectronics04/03/1998SE
K970886Hanaulux Blue 80 HospitalFSS · Traditional Heraeus Med GmbH04/16/1997SE
K961971Q-5000FSS · Traditional Stryker Endoscopy06/28/1996SE
K961074Lightsource or IlluminatorFSS · Traditional Cuda Products Co.04/30/1996SE

Questions and answers

When was Model FEL5100 Floor Light cleared by the FDA?

Model FEL5100 Floor Light (K895950) received a 510(k) decision of Substantially Equivalent on October 31, 1989, 21 days after the submission was received.

What is the product code of K895950?

The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.