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510(k) K932991

GUARDIAN AND ANDINO MODELS by Coltemp, Inc. — Product Code FLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
June 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Mercury
Device Class
Class II
Regulation Number
880.2920
Review Panel
HO
Submission Type

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