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 |