The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Ms Classique Balloon Catheter.
| Device ID | K944143 |
| 510k Number | K944143 |
| Device Name: | MS CLASSIQUE BALLOON CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Stephen B Anderson |
| Correspondent | Stephen B Anderson MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-25 |
| Decision Date | 1995-03-13 |