The following data is part of a premarket notification filed by Olympus Keymed (medical & Industrial Equipment) Lt with the FDA for Olympus Maj-172 Instrument Tray For Ltf Videoscope.
| Device ID | K122818 |
| 510k Number | K122818 |
| Device Name: | OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT 11440 WEST BERNARDO DRIVE SUITE 300 San Diego, CA 92127 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren OLYMPUS KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LT 11440 WEST BERNARDO DRIVE SUITE 300 San Diego, CA 92127 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-14 |
| Decision Date | 2013-01-04 |
| Summary: | summary |