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510(k) K831921

Device
DISPOSABLE MICROTOME BLADES
Applicant
POLYMER TECHNOLOGY CORP.
510(k) number
K831921
Product code
IDL  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-29
Date received
1983-06-14
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#

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 IDL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863616KNIFE MAKERSurgipath Medical Industries, Inc.1986-09-25
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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