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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
510(k) Number K813547
Device Name THERMASCAN
Applicant
Bcd Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bcd Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.2982
Classification Product Code
KXZ  
Date Received12/21/1981
Decision Date 03/12/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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