The following data is part of a premarket notification filed by Superdimension, Ltd. with the FDA for Modification To Superdimension/bronchus Premium 2.
| Device ID | K071473 |
| 510k Number | K071473 |
| Device Name: | MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | SUPERDIMENSION, LTD. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo SUPERDIMENSION, LTD. 555 ZANG STREET SUITE 100 Lakewood, CO 80228 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-07-12 |
| Summary: | summary |