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510(k) K891388

Device
1570 - FETAL BLOOD SAMPLING KIT
Applicant
TRANSIDYNE GENERAL CORP.
510(k) number
K891388
Product code
HGW  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-28
Date received
1989-03-14
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#

Contact
MARGARET K BEAUDET
Address
3711 Plz. Dr., #4 Ann Arbor MI US 48108 48108

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
K884685ROCKET FETAL BLOOD SAMPLING TRAYA & A Medical, Inc.1989-01-12
K831459FETAL BLOOD SAMPLING KIT #1560Transidyne General Corp.1983-06-30
K810028FETAL BLOOD SAMPLING KIT MODEL 1560Transidyne General Corp.1981-01-16

Legacy Summary#

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FDA Review#

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