The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Pbd Stents.
Device ID | K933200 |
510k Number | K933200 |
Device Name: | OLYMPUS PBD STENTS |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Barry E Sands |
Correspondent | Barry E Sands 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 | 1993-07-01 |
Decision Date | 1995-04-05 |