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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K000366
Device Name FIXATION STYLETS, MODELS 335-287 AND 335-288
Applicant
Accufix Research Institute
12503 E. Euclid Dr. # 20
Englewood,  CO  80111
Applicant Contact MICHAEL J ANDREWS
Correspondent
Accufix Research Institute
12503 E. Euclid Dr. # 20
Englewood,  CO  80111
Correspondent Contact MICHAEL J ANDREWS
Regulation Number870.1380
Classification Product Code
DRB  
Date Received02/04/2000
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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