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510(k) K896802

Device
MAGNET PAD
Applicant
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
510(k) number
K896802
Product code
LXG  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-27
Date received
1989-12-01
Regulation
862.2050
Classification name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SURY SHONEY
Address
1253 Ramona St. SE Grand Rapids MI US 49507 49507

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LXG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K021927PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEMBiomet, Inc.2002-07-12
K943466MINI S.F.T. (URINE PRESERVATIVE)Cambridge Diagnostic Products, Inc.1995-05-24

Legacy Summary#

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FDA Review#

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