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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 K950895
Device Name HARMAC EXTENSION INFUSION SET
Applicant
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO,  NY  14211 -1797
Applicant Contact JOSEPH M KONIECZNY
Correspondent
HARMAC MEDICAL PRODUCTS, INC.
2201 BAILEY AVE.
BUFFALO,  NY  14211 -1797
Correspondent Contact JOSEPH M KONIECZNY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/27/1995
Decision Date 09/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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