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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 K871529
Device Name TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO.
Applicant
Western Medical Equipment Corp.
2140 N. 107th St.
P.O. Box 309
Lafayette,  CO  80026
Applicant Contact ROBERT A STRIEBY
Correspondent
Western Medical Equipment Corp.
2140 N. 107th St.
P.O. Box 309
Lafayette,  CO  80026
Correspondent Contact ROBERT A STRIEBY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/20/1987
Decision Date 10/22/1987
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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