The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Xenf-dp Rhino-laryngofiberscope, Its Accessories And Ancillary Equipment.
| Device ID | K011869 |
| 510k Number | K011869 |
| Device Name: | XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-14 |
| Decision Date | 2001-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170318221 | K011869 | 000 |
| 04953170411335 | K011869 | 000 |
| 04953170411052 | K011869 | 000 |
| 04953170411069 | K011869 | 000 |
| 04953170050992 | K011869 | 000 |
| 04953170059018 | K011869 | 000 |
| 04953170059032 | K011869 | 000 |
| 04953170071683 | K011869 | 000 |
| 04953170078231 | K011869 | 000 |
| 04953170307188 | K011869 | 000 |
| 04953170318191 | K011869 | 000 |
| 04953170318207 | K011869 | 000 |
| 04953170318214 | K011869 | 000 |
| 04953170411076 | K011869 | 000 |