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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K853418
Device Name SAFTI-BRACELET
Applicant
ADVANCED BIOSEARCH ASSN.
3880 BLACKHAWK RD.
DANVILLE,  CA  94506 -4617
Applicant Contact BARRY M CALVARESE
Correspondent
ADVANCED BIOSEARCH ASSN.
3880 BLACKHAWK RD.
DANVILLE,  CA  94506 -4617
Correspondent Contact BARRY M CALVARESE
Regulation Number880.5210
Classification Product Code
KMK  
Date Received08/14/1985
Decision Date 09/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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