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FDA 510(k) Application Details - K961147
Device Classification Name
Catheter, Irrigation
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510(K) Number
K961147
Device Name
Catheter, Irrigation
Applicant
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM, PA 18018 US
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Contact
MARK S ALSBERGE
Other 510(k) Applications for this Contact
Regulation Number
878.4200
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Classification Product Code
GBX
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More FDA Info for this Product Code
Date Received
03/21/1996
Decision Date
05/31/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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