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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K030580
Device Name SURETEMP PLUS
Applicant
WELCH ALLYN, INC.
7420 CARROLL RD.
SAN DIEGO,  CA  92121 -2334
Applicant Contact DEBRA L JACKSON
Correspondent
WELCH ALLYN, INC.
7420 CARROLL RD.
SAN DIEGO,  CA  92121 -2334
Correspondent Contact DEBRA L JACKSON
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/24/2003
Decision Date 05/06/2003
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
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