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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
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 SW 47TH AVENUE
GAINESVILLE,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 SW 47TH AVENUE
GAINESVILLE,  FL  32608
Correspondent 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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