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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K952001
Device Name GEON ELECTRONIC THERMOMETER
Applicant
Geon Corp.
50 Gordon Dr.
Syosset,  NY  11791
Applicant Contact ILENE MANDELBAUM
Correspondent
Geon Corp.
50 Gordon Dr.
Syosset,  NY  11791
Correspondent Contact ILENE MANDELBAUM
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/28/1995
Decision Date 10/18/1996
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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