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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K012189
Device Name ANGELTOUCH VENTED IV ADMINISTRATION SET
Applicant
Angiplast Private , Ltd.
4803, Phase Iv, G.I.D.C.,
Vatva
Ahmedabad,  IN 382 445
Applicant Contact ASHIT B SHAH
Correspondent
Angiplast Private , Ltd.
4803, Phase Iv, G.I.D.C.,
Vatva
Ahmedabad,  IN 382 445
Correspondent Contact ASHIT B SHAH
Regulation Number880.5440
Classification Product Code
LHI  
Date Received07/12/2001
Decision Date 03/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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