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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 K820948
Device Name THREE SECOND THERMOMETER #TS-1000
Applicant
Temp-Stik Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Temp-Stik Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/06/1982
Decision Date 09/24/1982
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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