FDA.reportPublic FDA data

510(k) K810568

Device
PARAFFIN EMBEDDING MEDIUM
Applicant
SURGIPATH MEDICAL INDUSTRIES, INC.
510(k) number
K810568
Product code
KEO  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-17
Date received
1981-03-03
Regulation
864.4010
Classification name
Formulations, Paraffin, All
Medical specialty
Pathology
Review panel
Radiology
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 KEO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893772TISSUE EMBEDDING MEDIUMStephens Scientific1989-06-22
K862223MICRO THIN* PARAFFINRichard-Allan Medical Ind., Inc.1986-06-17
K862141HISTOLOGY PARAFFINErie Scientific Co.1986-06-13
K861270BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.Surgipath Medical Industries, Inc.1986-04-11
K842053PARAPLAST EXTRA TISSUE EMBEDDING MED.Sherwood Medical Co.1984-06-26
K833071TECHNICON PARACUTTechnicon Instruments Corp.1983-10-14
K831580PARAFFIN INFILTRATION MEDIUMSurgipath Medical Industries, Inc.1983-06-17
K812191VASPAR SEALENTAmerican Scientific Products1981-08-31
K803241HISTOLOGICAL EMBEDDING MEDIAMiles Laboratories, Inc.1981-01-28
K760602SORVALL EMBEDDING MEDIUME.I. Dupont DE Nemours & Co., Inc.1976-09-21

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