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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name I.V. Start Kit
510(k) Number K001879
Device Name INFUSION IV SET
Applicant
NIRVI INTL. USA
467 DIABLO DR.
PITTSBURG,  PA  15241
Applicant Contact DARSHANA HATHI
Correspondent
NIRVI INTL. USA
467 DIABLO DR.
PITTSBURG,  PA  15241
Correspondent Contact DARSHANA HATHI
Regulation Number880.5200
Classification Product Code
LRS  
Date Received06/20/2000
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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