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510(k) K881186

Device
MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
Applicant
HELPS PRODUCTS, INC.
510(k) number
K881186
Product code
GHY  
Decision
Substantially Equivalent (SESE)
Decision date
1988-05-13
Date received
1988-03-21
Regulation
864.6400
Classification name
Hematocrit, Tube, Rack, Sealer, Holder
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRIAN LEMAY
Address
4469 Sw35th.St. Orlando FL US 32811 32811

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883185SAFECRIT PLASTIC MICROHEMATOCRIT TUBESNorfolk Scientific, Inc.1988-08-18

Legacy Summary#

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FDA Review#

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