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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 K890202
Device Name TELE-TEMP THERMOMETER
Applicant
Rocky Mountain Medical Corp.
5680 Greenwood Plz. Blvd.
P.O. Box 4783
Englewood,  CO  80155
Applicant Contact J ROSENBAUM
Correspondent
Rocky Mountain Medical Corp.
5680 Greenwood Plz. Blvd.
P.O. Box 4783
Englewood,  CO  80155
Correspondent Contact J ROSENBAUM
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/17/1989
Decision Date 04/05/1989
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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