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510(k) K920177

Device
VERSA-VIAL
Applicant
BIOTEQUE AMERICA, INC.
510(k) number
K920177
Product code
DQF  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-13
Date received
1992-01-14
Regulation
870.1670
Classification name
Actuator, Syringe, Injector Type
Medical specialty
Cardiovascular
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DENIS DORSEY
Address
51 Rainlily Rd. Levittown PA US 19056 19056

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882723ALCON FLUID INJECTORAlcon Laboratories1988-11-08
K880740MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGESpectramed, Inc.1988-03-22

Legacy Summary#

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FDA Review#

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