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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K914867
Device Name QWIK-1(TM) IN-LINE IV FLUID WARMER
Applicant
Microwave Medical Systems, Inc.
9 Goldsmith St.
P.O. Box 188
Littleton,  MA  01460 -0188
Applicant Contact RICHARD S GRABOWY
Correspondent
Microwave Medical Systems, Inc.
9 Goldsmith St.
P.O. Box 188
Littleton,  MA  01460 -0188
Correspondent Contact RICHARD S GRABOWY
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received10/29/1991
Decision Date 10/23/1992
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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