The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Ltf-240 Pleuravideoscope, Its Accessories And Ancillary Equipments.
| Device ID | K013617 |
| 510k Number | K013617 |
| Device Name: | LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2002-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340284 | K013617 | 000 |
| 04953170154492 | K013617 | 000 |
| 04953170140594 | K013617 | 000 |
| 14953170048958 | K013617 | 000 |
| 14953170048828 | K013617 | 000 |