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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 K873010
Device Name SURFACE TEMPERATURE SCANNER
Applicant
Omega Medical Corp.
251-A Windward Passage
Clearwater,  FL  34630
Applicant Contact LOONEY, JR
Correspondent
Omega Medical Corp.
251-A Windward Passage
Clearwater,  FL  34630
Correspondent Contact LOONEY, JR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/04/1987
Decision Date 11/17/1987
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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