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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K930745
Device Name BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER
Applicant
B. BRAUN MEDICAL, INC.
13000 HWY. 55
PLYMOUTH,  MN  55441 -3813
Applicant Contact WILLIAM RYAN
Correspondent
B. BRAUN MEDICAL, INC.
13000 HWY. 55
PLYMOUTH,  MN  55441 -3813
Correspondent Contact WILLIAM RYAN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/12/1993
Decision Date 05/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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