FDA.report

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

Related Records

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)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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