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510(k) K862141

Device
HISTOLOGY PARAFFIN
Applicant
ERIE SCIENTIFIC CO.
510(k) number
K862141
Product code
KEO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-06-13
Date received
1986-06-04
Regulation
864.4010
Classification name
Formulations, Paraffin, All
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HENRY N WILLIAMS
Address
Portsmouth Industrial Park Portsmouth NH US 03801 03801

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
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
K810568PARAFFIN EMBEDDING MEDIUMSurgipath Medical Industries, Inc.1981-03-17
K803241HISTOLOGICAL EMBEDDING MEDIAMiles Laboratories, Inc.1981-01-28
K760602SORVALL EMBEDDING MEDIUME.I. Dupont DE Nemours & Co., Inc.1976-09-21

Legacy Summary#

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FDA Review#

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