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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name anesthesia conduction kit
510(k) Number K971233
Device Name SOFT TIP EPIDURAL CATHETER KIT
Applicant
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Applicant Contact MARK S ALBERGE
Correspondent
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact MARK S ALBERGE
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/02/1997
Decision Date 10/17/1997
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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