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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 K926030
Device Name KLEAR-TEMP
Applicant
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Applicant Contact EDWARD W JACKSON
Correspondent
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Correspondent Contact EDWARD W JACKSON
Regulation Number880.5130
Classification Product Code
FMT  
Subsequent Product Code
FMZ  
Date Received12/01/1992
Decision Date 02/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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