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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
Applicant Contact JOSEPH M KONIECZNY
Correspondent
Harmac Medical Products, Inc.
2201 Bailey Ave.
Buffalo,  NY  14211
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
Predetermined Change
Control Plan Authorized		 No
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