The following data is part of a premarket notification filed by Technology Marketing Group with the FDA for Ultathin Flexible Endoscope.
| Device ID | K941715 |
| 510k Number | K941715 |
| Device Name: | ULTATHIN FLEXIBLE ENDOSCOPE |
| Classification | Angioscope |
| Applicant | TECHNOLOGY MARKETING GROUP 525 PALMER AVE. Maywood, NJ 07607 |
| Contact | Thomas Hynes |
| Correspondent | Thomas Hynes TECHNOLOGY MARKETING GROUP 525 PALMER AVE. Maywood, NJ 07607 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-07 |
| Decision Date | 1994-10-04 |