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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 K952800
Device Name TEMPERATURE PROBE-TP150
Applicant
Contour Medical Technology, Inc.
144 Southway Blvd.
P.O. Box 397
Lavergne,  TN  37086
Applicant Contact R. KEITH FERRARI
Correspondent
Contour Medical Technology, Inc.
144 Southway Blvd.
P.O. Box 397
Lavergne,  TN  37086
Correspondent Contact R. KEITH FERRARI
Regulation Number880.5130
Classification Product Code
FMT  
Date Received06/19/1995
Decision Date 04/04/1996
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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