The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Guide Sheath, Model Xbo1-836-13.
| Device ID | K060243 |
| 510k Number | K060243 |
| Device Name: | OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-31 |
| Decision Date | 2006-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170245548 | K060243 | 000 |
| 14953170245524 | K060243 | 000 |
| 14953170245500 | K060243 | 000 |
| 14953170245487 | K060243 | 000 |
| 14953170245463 | K060243 | 000 |
| 14953170062237 | K060243 | 000 |