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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 K950597
Device Name CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE
Applicant
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801
Applicant Contact JOYCE MCDOUGALL
Correspondent
Distronic Sterile Products, Inc.
124 Heritage Ave.
Portsmouth,  NH  03801
Correspondent Contact JOYCE MCDOUGALL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/09/1995
Decision Date 07/26/1995
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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