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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K071977
Device Name TARRY MEDICAL TEMPERATURE PROBES
Applicant
Tarry Medical Products, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Tarry Medical Products, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
FMT  
Date Received07/17/2007
Decision Date 05/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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