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510(k) K760500

Device
TUBE, HEAVY GLASS WALL INJECTION
Applicant
UNIMETRICS CORP.
510(k) number
K760500
Product code
DXL  
Decision
Substantially Equivalent (SESE)
Decision date
1976-09-03
Date received
1976-08-23
Regulation
870.1660
Classification name
Injector, Indicator
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DXL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K760448SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECTInstrumentation Laboratory CO1976-08-27
K760066TRAY, ICED INJECTABLE (26420)Instrumentation Laboratory CO1976-07-21

Legacy Summary#

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FDA Review#

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