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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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