510(k) K934084
- Device
- BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
- Applicant
- BIOENTERICS CORP.
- 510(k) number
- K934084
- Product code
- HMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-12-16
- Date received
- 1993-08-20
- Regulation
- 886.1810
- Classification name
- Screen, Tangent, Projection, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID D WELLINGTON
- Address
- 1035 A. Cindy Ln. Carpinteria CA US 93013 93013
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HMJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924753 | BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE | Bioenterics Corp. | 1992-12-15 |
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