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510(k) K842732

Device
ZENKERS SOLUTION
Applicant
E K IND., INC.
510(k) number
K842732
Product code
IFH  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-03
Date received
1984-07-13
Regulation
864.4010
Classification name
Solution, Zenker's
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IFH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K822127VOLU-SOL ZENKERS FIXATIVEVolu Sol Medical Industries1982-08-05

Legacy Summary#

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FDA Review#

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