FDA 510(k) Application Details - K952541

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K952541
Device Name Thermometer, Electronic, Clinical
Applicant REGITAR U.S.A., INC.
2776 GUTNER PARK DRIVE EAST
MONTGOMERY, AL 36109 US
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Contact Y. T. TSAI
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 04/28/1995
Decision Date 01/02/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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