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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 K850363
Device Name POLLENEX DIGITAL THERMOMETER T-225
Applicant
ASSOCIATED MILLS, INC.
165 NORTH CANAL ST.
CHICAGO,  IL  60606
Applicant Contact ROSSIER
Correspondent
ASSOCIATED MILLS, INC.
165 NORTH CANAL ST.
CHICAGO,  IL  60606
Correspondent Contact ROSSIER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/30/1985
Decision Date 02/15/1985
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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