The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Hd Endoeye Laparo-thoraco Videoscope Olympus Ltf Type Vh.
| Device ID | K080948 |
| 510k Number | K080948 |
| Device Name: | HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | HET |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | NWB |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170310355 | K080948 | 000 |
| 04953170287015 | K080948 | 000 |