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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K801573
Device Name SAPCRILL THERMODETECT BREAST SCANNER DEV
Applicant
California Cardiac Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
California Cardiac Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received07/09/1980
Decision Date 09/09/1980
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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