The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Ltf-y0009; Maj-yoo41; Xoev-3d1.
| Device ID | K102379 |
| 510k Number | K102379 |
| Device Name: | LTF-Y0009; MAJ-YOO41; XOEV-3D1 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy A Kluesner, M.s. Rac |
| Correspondent | Stacy A Kluesner, M.s. Rac 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 | 2010-08-23 |
| Decision Date | 2011-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170363498 | K102379 | 000 |