The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Laparo-thoraco Videoscope Xltf-vaw.
| Device ID | K053382 |
| 510k Number | K053382 |
| Device Name: | LAPARO-THORACO VIDEOSCOPE XLTF-VAW |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Tracy Gulsen |
| Correspondent | Tracy Gulsen OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170353222 | K053382 | 000 |
| 04953170025570 | K053382 | 000 |
| 04953170025563 | K053382 | 000 |
| 04953170023118 | K053382 | 000 |
| 04953170022746 | K053382 | 000 |