The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Oes Thoracoscope System.
Device ID | K912362 |
510k Number | K912362 |
Device Name: | OES THORACOSCOPE SYSTEM |
Classification | Mediastinoscope, Surgical |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Daniel J Dillon |
Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | EWY |
CFR Regulation Number | 874.4720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-29 |
Decision Date | 1991-10-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04042761074032 | K912362 | 000 |
04042761008679 | K912362 | 000 |
04042761052771 | K912362 | 000 |
04042761052764 | K912362 | 000 |
04042761052757 | K912362 | 000 |
04042761004961 | K912362 | 000 |
04042761004954 | K912362 | 000 |
04042761004886 | K912362 | 000 |
04042761004800 | K912362 | 000 |
04042761031035 | K912362 | 000 |
04042761031042 | K912362 | 000 |
04042761031059 | K912362 | 000 |
04042761074025 | K912362 | 000 |
04042761074018 | K912362 | 000 |
04042761074001 | K912362 | 000 |
04042761068796 | K912362 | 000 |
04042761052801 | K912362 | 000 |
04042761031097 | K912362 | 000 |
04042761031080 | K912362 | 000 |
04042761031073 | K912362 | 000 |
04042761041539 | K912362 | 000 |