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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 K832090
Device Name SCD SKIN TEMP. SENSORS #3400 ETC
Applicant
Science Development Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Science Development Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/28/1983
Decision Date 10/31/1983
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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