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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 K950970
Device Name INFUSION SET
Applicant
Surgiplast , Ltd.
80/4 G.I.D.C. Vatva
Ahmedabad 382 445,  IN
Applicant Contact ASHIT B SHAH
Correspondent
Surgiplast , Ltd.
80/4 G.I.D.C. Vatva
Ahmedabad 382 445,  IN
Correspondent Contact ASHIT B SHAH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/02/1995
Decision Date 12/18/1995
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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