Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name dilator, esophageal
510(k) Number K983373
Device Name IMPACT BALLOON DILATION CATHETER
Applicant
B. BRAUN/MCGAW
824 12TH AVE.
BETHLEHEM,  PA  18018 -0027
Applicant Contact MARK S ALSBERGE
Correspondent
B. BRAUN/MCGAW
824 12TH AVE.
BETHLEHEM,  PA  18018 -0027
Correspondent Contact MARK S ALSBERGE
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received09/24/1998
Decision Date 06/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-