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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 K853794
Device Name NEOGUARD REFLECTOR
Applicant
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Applicant Contact JOEL N HELFER
Correspondent
Cas Medical Systems, Inc.
29 Business Park Dr.
Branford,  CT  06405
Correspondent Contact JOEL N HELFER
Regulation Number880.5130
Classification Product Code
FMT  
Date Received09/11/1985
Decision Date 10/16/1985
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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