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510(k) K831333

Device
EMBEDDING RINGS
Applicant
SURGIPATH MEDICAL INDUSTRIES, INC.
510(k) number
K831333
Product code
KER  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-25
Date received
1983-04-25
Regulation
864.3010
Classification name
Container, Embedding
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
MD US

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KER  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K831922EMBEDDING RINGPolymer Technology Corp.1983-07-29
K831900MACLEAN-FOGG, DISP. BASE MOLDPolymer Technology Corp.1983-07-28
K831335DISPOSABLE BASE MOLDSurgipath Medical Industries, Inc.1983-05-16
K772149LANCER BIOPSY HOLDERSherwood Medical Industries1977-11-22

Legacy Summary#

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FDA Review#

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