510(k) K924753
- Device
- BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
- Applicant
- BIOENTERICS CORP.
- 510(k) number
- K924753
- Product code
- HMJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-15
- Date received
- 1992-09-22
- 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
- DELORES GRAHAM
- 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 |
|---|---|---|---|
| K934084 | BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE | Bioenterics Corp. | 1993-12-16 |
Legacy Summary#
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FDA Review#
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