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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K002533
Device Name TCD 100M, PWD13 TRANSDUCER
Applicant
SPENCER TECHNOLOGIES
701 16TH AVE.
seattle,  WA  98122
Applicant Contact tony williams
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
northbrook,  IL  60062
Regulation Number892.1550
Classification Product Code
IYN  
Date Received08/16/2000
Decision Date 08/30/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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