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510(k) K880740

Device
MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
Applicant
SPECTRAMED, INC.
510(k) number
K880740
Product code
DQF  
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-22
Date received
1988-02-24
Regulation
870.1670
Classification name
Actuator, Syringe, Injector Type
Medical specialty
Cardiovascular
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT L LEAVITT
Address
1900 Williams Dr. Oxnard CA US 93030 93030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DQF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920177VERSA-VIALBioteque America, Inc.1992-07-13
K882723ALCON FLUID INJECTORAlcon Laboratories1988-11-08

Legacy Summary#

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FDA Review#

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