The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Laparoscopic Cholangiography Catheterization Sets.
| Device ID | K905229 |
| 510k Number | K905229 |
| Device Name: | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Thomas Nickel |
| Correspondent | Thomas Nickel ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-01-18 |