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510(k) K892522

Device
SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
Applicant
GESPAC, INC.
510(k) number
K892522
Product code
GKB  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-24
Date received
1989-04-11
Regulation
864.5800
Classification name
Device, Automated Sedimentation Rate
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
COSMA PABOUCTSIDIS
Address
50 W. Hoover Ave. Mesa AZ US 85210 85210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GKB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890503SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATEGespac, Inc.1989-02-10

Legacy Summary#

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FDA Review#

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