FDA 510(k) Application Details - K030580

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K030580
Device Name Thermometer, Electronic, Clinical
Applicant WELCH ALLYN, INC.
7420 CARROLL RD.
SAN DIEGO, CA 92121-2334 US
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Contact DEBRA L JACKSON
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 02/24/2003
Decision Date 05/06/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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