510(k) K895084
- Device
- APERTURE
- Applicant
- CUSTOM MEDICAL PRODUCTS, LTD.
- 510(k) number
- K895084
- Product code
- IZS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-27
- Date received
- 1989-08-14
- Regulation
- 892.1610
- Classification name
- Aperture, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES COLLETTE
- Address
- 19a W. Industry Ct. Deer Park NY US 11729 11729
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