Magnet Pad

FDA 510(k) K896802 · Westmark, Sterile Packing Systems, Inc. (Sps)

Substantially Equivalent

510(k) numberK896802

Submission

Device name
Magnet Pad
Applicant
Westmark, Sterile Packing Systems, Inc. (Sps)
Grand Rapids, MI, US
Received
December 1, 1989
Decision date
December 27, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LXG – Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Specialty
Clinical Chemistry

Other 510(k)s with product code LXG

510(k)DeviceApplicantDecision
K021927Platelet Concentrate Separation Kit for Celsep Centrifuge SystemLXG · Special Biomet, Inc.07/12/2002SE
K943466Mini S.F.T. (Urine Preservative)LXG · Traditional Cambridge Diagnostic Products, Inc.05/24/1995SE

More from Cambridge Diagnostic Products, Inc.

510(k)DeviceDecision
K896800Irrigation TrayKYZ · Traditional 05/24/1990SESK
K896799Paracervical/Pudendal TraysCAZ · Traditional 04/23/1990SE
K896559Infant Feeding TubeFPD · Traditional 03/13/1990SE
K896794Specimen ContainerLIO · Traditional 03/01/1990SE
K896806Catheter Plug/ProtectorKNY · Traditional 02/26/1990SE
K896798Tracheostomy TrayBTO · Traditional 02/22/1990SE
K896797Suction Catheter KitBSY · Traditional 02/16/1990SE
K896215Mercy Hip/Knee PackKKX · Traditional 02/13/1990SE
K896804ManifoldGCX · Traditional 02/08/1990SE
K896563Tubing ConnectorsGCX · Traditional 02/06/1990SE

Questions and answers

When was Magnet Pad cleared by the FDA?

Magnet Pad (K896802) received a 510(k) decision of Substantially Equivalent on December 27, 1989, 26 days after the submission was received.

What is the product code of K896802?

The FDA product code is LXG – Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.