The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Ms Classique Balloon Dilatation Cahteter.
| Device ID | K953332 |
| 510k Number | K953332 |
| Device Name: | MS CLASSIQUE BALLOON DILATATION CAHTETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Stephen Anderson |
| Correspondent | Stephen Anderson MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 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 | 1995-07-17 |
| Decision Date | 1995-10-07 |