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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 K021916
Device Name HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
Applicant
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO,  NY  14211 -1797
Applicant Contact ROBERT F MORAN
Correspondent
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO,  NY  14211 -1797
Correspondent Contact ROBERT F MORAN
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Codes
FMI   LJT  
Date Received06/11/2002
Decision Date 08/29/2002
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
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