The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Olympus Ltf-s190-10, Olumpus Otv-s190, Olympus Clv-s190.
| Device ID | K111425 |
| 510k Number | K111425 |
| Device Name: | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri Musgnung OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | HET |
| Subsequent Product Code | EOB |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | FGB |
| 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 | 2011-05-23 |
| Decision Date | 2012-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170310386 | K111425 | 000 |
| 04953170304880 | K111425 | 000 |
| 04953170305054 | K111425 | 000 |
| 04953170305078 | K111425 | 000 |
| 04953170305092 | K111425 | 000 |
| 04953170434662 | K111425 | 000 |
| 04953170148545 | K111425 | 000 |
| 04953170301964 | K111425 | 000 |
| 04953170301995 | K111425 | 000 |
| 04953170304842 | K111425 | 000 |