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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 K950305
Device Name QTMICRO(TM) SYSTEM
Applicant
Q.I. Medical, Inc.
111-B New Mohawk Rd.
P.O. Box 1329
Nevada City,  CA  95959
Applicant Contact HILARY R HEDMAN
Correspondent
Q.I. Medical, Inc.
111-B New Mohawk Rd.
P.O. Box 1329
Nevada City,  CA  95959
Correspondent Contact HILARY R HEDMAN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/25/1995
Decision Date 10/13/1995
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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