The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Xenf-tp Rhino-laryngofiberscope, Its Acessories And Ancillary Equipment.
| Device ID | K013591 |
| 510k Number | K013591 |
| Device Name: | XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-30 |
| Decision Date | 2001-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170062407 | K013591 | 000 |
| 14953170044356 | K013591 | 000 |
| 14953170044332 | K013591 | 000 |
| 14953170044318 | K013591 | 000 |
| 14953170453752 | K013591 | 000 |
| 04953170438219 | K013591 | 000 |
| 84953170063356 | K013591 | 000 |
| 04953170434419 | K013591 | 000 |
| 04953170071676 | K013591 | 000 |
| 14953170044370 | K013591 | 000 |
| 14953170044400 | K013591 | 000 |
| 14953170062398 | K013591 | 000 |
| 04953170060601 | K013591 | 000 |
| 14953170059206 | K013591 | 000 |
| 14953170049047 | K013591 | 000 |
| 14953170044509 | K013591 | 000 |
| 14953170044479 | K013591 | 000 |
| 14953170044455 | K013591 | 000 |
| 14953170044424 | K013591 | 000 |
| 04953170063350 | K013591 | 000 |