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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name warmer, infant radiant
510(k) Number K931529
Device Name INFANT WARMER
Applicant
MEDIX I.C.S.A.
CALLE 89 JOSE ARIAS 293
SAN MARTIN, BUENOS AIRES,  AR B1672ACA
Applicant Contact CARLOS GUERRA
Correspondent
MEDIX I.C.S.A.
CALLE 89 JOSE ARIAS 293
SAN MARTIN, BUENOS AIRES,  AR B1672ACA
Correspondent Contact CARLOS GUERRA
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/26/1993
Decision Date 03/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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