The following data is part of a premarket notification filed by Technology Marketing Group with the FDA for Tas-211/2.3 Ultrathin Flexible Endoscope.
| Device ID | K935834 |
| 510k Number | K935834 |
| Device Name: | TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | TECHNOLOGY MARKETING GROUP 525 PALMER AVE. Maywood, NJ 07607 |
| Contact | Thomas Hynes, Esq. |
| Correspondent | Thomas Hynes, Esq. TECHNOLOGY MARKETING GROUP 525 PALMER AVE. Maywood, NJ 07607 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-07 |
| Decision Date | 1994-03-07 |