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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K990693
Device Name FLEXNEEDLE PLUS
Applicant
ACT MEDICAL, INC.
150 CALIFORNIA ST.
NEWTON,  MA  02458
Applicant Contact WENDY V SHOTTS
Correspondent
ACT MEDICAL, INC.
150 CALIFORNIA ST.
NEWTON,  MA  02458
Correspondent Contact WENDY V SHOTTS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/03/1999
Decision Date 05/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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