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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K002416
Device Name GOLDEN-RULE SCALING CATHETER
Original Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 sw 47th avenue
gainesville,  FL  32608
Original Contact karl swartz
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/08/2000
Decision Date 09/11/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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