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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K960406
Device Name BRAUN HEMOSTASIS INTRODUCERS
Applicant
B.Braun Medical, Inc.
1300 Hwy. 55
Minneapolis,  MN  55411
Applicant Contact BARBARA ATZENHOEFER
Correspondent
B.Braun Medical, Inc.
1300 Hwy. 55
Minneapolis,  MN  55411
Correspondent Contact BARBARA ATZENHOEFER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/29/1996
Decision Date 04/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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