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510(k) K810028

Device
FETAL BLOOD SAMPLING KIT MODEL 1560
Applicant
TRANSIDYNE GENERAL CORP.
510(k) number
K810028
Product code
HGW  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-16
Date received
1981-01-06
Regulation
884.1560
Classification name
Sampler, Blood, Fetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K8913881570 - FETAL BLOOD SAMPLING KITTransidyne General Corp.1989-03-28
K884685ROCKET FETAL BLOOD SAMPLING TRAYA & A Medical, Inc.1989-01-12
K831459FETAL BLOOD SAMPLING KIT #1560Transidyne General Corp.1983-06-30

Legacy Summary#

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FDA Review#

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