The following data is part of a premarket notification filed by Mitsubishi Cable America, Inc. with the FDA for Ultrathin Flexible Endoscope Tas-211/2.3.
| Device ID | K936257 |
| 510k Number | K936257 |
| Device Name: | ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3 |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | MITSUBISHI CABLE AMERICA, INC. 525 PALMER AVE. Maywood, NJ 07607 |
| Contact | Thomas Hynes, Esq |
| Correspondent | Thomas Hynes, Esq MITSUBISHI CABLE AMERICA, INC. 525 PALMER AVE. Maywood, NJ 07607 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-03-24 |