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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 Color Change
510(k) Number K853515
Device Name PEE WEE THERMOMETERS
Applicant
Joel R.L. Ehren Kranz
60 Franklin St.
Morristown,  NJ  07960
Applicant Contact EHREN KRAN
Correspondent
Joel R.L. Ehren Kranz
60 Franklin St.
Morristown,  NJ  07960
Correspondent Contact EHREN KRAN
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received08/22/1985
Decision Date 10/16/1985
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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