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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 K955659
Device Name DRUGBOX
Applicant
C.F. Electronics, Inc.
5 Brayton Ct.
Commack,  NY  11725
Applicant Contact ROBERT P FREEDMAN
Correspondent
C.F. Electronics, Inc.
5 Brayton Ct.
Commack,  NY  11725
Correspondent Contact ROBERT P FREEDMAN
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received12/12/1995
Decision Date 05/14/1996
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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