The following data is part of a premarket notification filed by Bioenterics Corp. with the FDA for Bioentrics Endolumina Illuminated Bougie.
| Device ID | K924753 |
| 510k Number | K924753 |
| Device Name: | BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE |
| Classification | Screen, Tangent, Projection, Battery-powered |
| Applicant | BIOENTERICS CORP. 1035 A CINDY LN. Carpinteria, CA 93013 |
| Contact | Delores Graham |
| Correspondent | Delores Graham BIOENTERICS CORP. 1035 A CINDY LN. Carpinteria, CA 93013 |
| Product Code | HMJ |
| CFR Regulation Number | 886.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-22 |
| Decision Date | 1992-12-15 |