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510(k) K863483

Device
CASSETTE EMBOSSEER
Applicant
SURGIPATH MEDICAL INDUSTRIES, INC.
510(k) number
K863483
Product code
IDZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-16
Date received
1986-09-09
Regulation
864.3010
Classification name
Cassettes, Tissue
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
URBAN, HT
Address
P.O. Box 769 Grayslake IL US 60030 60030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IDZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862457LYNX EL MICROSCOPY TISSUE PROCESSORAustralian Biomedical Corporation , Ltd.1986-07-16
K833857MACLEAN-FOGG, TISSUE CASSETTESPolymer Technology Corp.1983-12-02
K831334TISSUE CASSETTES FOR PROCESSING-EM BEDSurgipath Medical Industries, Inc.1983-05-25
K760623LANCER PARAPLAST HISTO PROCESS CASSETTESherwood Medical Industries1976-09-27

Legacy Summary#

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FDA Review#

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