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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 K960224
Device Name GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
Applicant
Rg Ent., Inc.
4217 Highland Rd., #279
Waterford,  MI  48328
Applicant Contact DANIEL L. R GECZI
Correspondent
Rg Ent., Inc.
4217 Highland Rd., #279
Waterford,  MI  48328
Correspondent Contact DANIEL L. R GECZI
Regulation Number880.2920
Classification Product Code
FLK  
Date Received01/17/1996
Decision Date 03/25/1996
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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