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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K945184
Device Name INTRAVASCULAR ADMINISTRATION SET
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
FPK  
Subsequent Product Code
FPA  
Date Received10/24/1994
Decision Date 02/08/1995
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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