The following data is part of a premarket notification filed by B. Braun/mcgaw with the FDA for Impact Balloon Dilation Catheter.
| Device ID | K983373 |
| 510k Number | K983373 |
| Device Name: | IMPACT BALLOON DILATION CATHETER |
| Classification | Dilator, Esophageal |
| Applicant | B. BRAUN/MCGAW 824 12TH AVE. Bethlehem, PA 18018 -0027 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN/MCGAW 824 12TH AVE. Bethlehem, PA 18018 -0027 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-24 |
| Decision Date | 1999-06-22 |