The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Single Use Balloon Dilator Maxpasstm.
Device ID | K050502 |
510k Number | K050502 |
Device Name: | SINGLE USE BALLOON DILATOR MAXPASSTM |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-28 |
Decision Date | 2005-07-08 |
Summary: | summary |