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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, catheter
510(k) Number K150800
Device Name Valved Safety Centesis Catheter
Applicant
B. Braun Medical Inc
901 Marcon Blvd
Allentown,  PA  18109
Applicant Contact Nancy Skocypec
Correspondent
B. Braun Medical Inc
901 Marcon Blvd
Allentown,  PA  18109
Correspondent Contact Nancy Skocypec
Regulation Number878.4200
Classification Product Code
GCB  
Date Received03/26/2015
Decision Date 11/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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