The following data is part of a premarket notification filed by Bioenterics Corp. with the FDA for Endolumina Ii Transillumination System 56fr E-5630, 50fr E-5030 And 40fr E-4020, Endolumina Ii Detachable Tips, 56fr, Ta.
| Device ID | K964561 |
| 510k Number | K964561 |
| Device Name: | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA |
| Classification | Retractor, Fiberoptic |
| Applicant | BIOENTERICS CORP. 1035A CINDY LN. Carpinteria, CA 93013 |
| Contact | Keith Lowrey |
| Correspondent | Keith Lowrey BIOENTERICS CORP. 1035A CINDY LN. Carpinteria, CA 93013 |
| Product Code | FDG |
| CFR Regulation Number | 876.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-13 |
| Decision Date | 1997-02-11 |
| Summary: | summary |