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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K993698
Device Name SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
Applicant
Mogul Enterprises
6387 San Ignacio Ave.
San Jose,  CA  95119
Applicant Contact JAMIL MOGUL
Correspondent
Mogul Enterprises
6387 San Ignacio Ave.
San Jose,  CA  95119
Correspondent Contact JAMIL MOGUL
Regulation Number870.1220
Classification Product Code
DRF  
Date Received11/02/1999
Decision Date 08/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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