510(k) K895772
- Device
- EXEL INDWELLING CATHETER
- Applicant
- EXEL INTL.
- 510(k) number
- K895772
- Product code
- FDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-16
- Date received
- 1989-09-26
- Regulation
- 876.1500
- Classification name
- Attachment, Eyepiece, For Insertion Of Prescription Lens
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ESHAGH HAMID
- Address
- P.O. Box 3194 Culver City CA US 90231 90231
FDA Registration Numbers#
- 3012322232
- 3010202439
- 3010041511
- 2020550
- 3011137372
- 3014342096
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FDZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852642 | CENTRAL VEIN CATHETERIZATION TRAY | Teleflexmedical, Inc. | 1986-01-16 |
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