The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Olympus Ltf-190-10-3d, Maj-y0154, Olympus Cv-190.
| Device ID | K123365 |
| 510k Number | K123365 |
| Device Name: | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | HET |
| 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 | 2012-10-31 |
| Decision Date | 2013-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170340710 | K123365 | 000 |
| 04953170338281 | K123365 | 000 |
| 04953170338274 | K123365 | 000 |
| 04953170338267 | K123365 | 000 |
| 04953170338250 | K123365 | 000 |
| 04953170338243 | K123365 | 000 |
| 04953170338229 | K123365 | 000 |
| 04953170434938 | K123365 | 000 |