510(k) K852045
- Device
- SED-FIX CONCENTRATE
- Applicant
- SURGIPATH MEDICAL INDUSTRIES, INC.
- 510(k) number
- K852045
- Product code
- IER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-06-10
- Date received
- 1985-05-09
- Regulation
- 864.4010
- Classification name
- Polyethylene Glycol (carbowax)
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOY F MONEK
- Address
- P.O. Box 769 Grayslake IL US 60030 60030
FDA Registration Numbers#
- 1419341
- 3002805583
Source Documents#
510(k) summary PDF not indicated by FDA
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