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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 K910915
Device Name PATIENT WARMER MODEL 100C
Applicant
DEVELOPMED CORP.
P.O. BOX 27342
HOUSTON,  TX  77227
Applicant Contact CHARLES BOYD
Correspondent
DEVELOPMED CORP.
P.O. BOX 27342
HOUSTON,  TX  77227
Correspondent Contact CHARLES BOYD
Regulation Number880.5130
Classification Product Code
FMT  
Date Received03/05/1991
Decision Date 07/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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