The following data is part of a premarket notification filed by Bioenterics Corp. with the FDA for Bioenterics Endolumina Illuminating Bougie.
| Device ID | K934084 |
| 510k Number | K934084 |
| Device Name: | BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE |
| Classification | Screen, Tangent, Projection, Battery-powered |
| Applicant | BIOENTERICS CORP. 1035 A CINDY LN. Carpinteria, CA 93013 |
| Contact | David D Wellington |
| Correspondent | David D Wellington 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 | 1993-08-20 |
| Decision Date | 1993-12-16 |