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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 K911383
Device Name HOTLINE FLUID WARMER
Applicant
LEVEL 1 TECHNOLOGIES, INC.
8904 PADDOCK LN.
POTOMAC,  MD  20854
Applicant Contact BERNARD KONOPKO
Correspondent
LEVEL 1 TECHNOLOGIES, INC.
8904 PADDOCK LN.
POTOMAC,  MD  20854
Correspondent Contact BERNARD KONOPKO
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received03/28/1991
Decision Date 10/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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