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510(k) K863616

Device
KNIFE MAKER
Applicant
SURGIPATH MEDICAL INDUSTRIES, INC.
510(k) number
K863616
Product code
IDL  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-25
Date received
1986-09-16
Regulation
864.3010
Classification name
Microtome, Accessories
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
URBAN, HT(ASCP)
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 IDL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831921DISPOSABLE MICROTOME BLADESPolymer Technology Corp.1983-07-29
K831308DISPOSABLE MICROTOME BLADESurgipath Medical Industries, Inc.1983-05-16
K813430TISSUE PROCESSING CASSETTES & ACCESSAmerican Optical Corp.1981-12-29
K801426TISSUE-TEK III MICROJECT DISP. BLADE SYSMiles Laboratories, Inc.1980-07-28

Legacy Summary#

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FDA Review#

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