The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Pr Cannulas.
Device ID | K902734 |
510k Number | K902734 |
Device Name: | PR CANNULAS |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Daniel Dillon |
Correspondent | Daniel Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-21 |
Decision Date | 1990-08-22 |