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510(k) K781698

Device
EXAMINER 10
Applicant
AMERICAN STERILIZER CO.
510(k) number
K781698
Product code
HJE  
Decision
Substantially Equivalent (SESE)
Decision date
1978-11-03
Date received
1978-10-10
Regulation
878.4580
Classification name
Lamp, Fluorescein, Ac-powered
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K922348VALTRAC(R) INTRODUCER FORCEPAmerican Cyanamid Co.1992-06-09
K802291FLUORESCENT SUN LAMP FIXTUREStrato-Ray Co.1980-10-31

Legacy Summary#

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FDA Review#

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