FDA.reportPublic FDA data

510(k) K831335

Device
DISPOSABLE BASE MOLD
Applicant
SURGIPATH MEDICAL INDUSTRIES, INC.
510(k) number
K831335
Product code
KER  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-16
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
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 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
K831333EMBEDDING RINGSSurgipath Medical Industries, Inc.1983-05-25
K772149LANCER BIOPSY HOLDERSherwood Medical Industries1977-11-22

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases