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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K941673
Device Name MEDIAID UNIVERSAL THERMOMETER
Applicant
Polymedica Industries, Inc.
581 Conference Pl.
Golden,,  CO  80401
Applicant Contact ANDREW M REED
Correspondent
Polymedica Industries, Inc.
581 Conference Pl.
Golden,,  CO  80401
Correspondent Contact ANDREW M REED
Regulation Number880.2920
Classification Product Code
FLK  
Date Received04/05/1994
Decision Date 08/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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