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 |